Articles tagged as "United States of America"

Peer support: not a panacea for poor adherence

Use of peers to improve adherence to antiretroviral therapy: a global network meta-analysis.

Kanters S, Park JJ, Chan K, Ford N, Forrest J, Thorlund K, Nachega JB, Mills EJ. J Int AIDS Soc. 2016 Nov 30;19(1):21141. doi: 10.7448/IAS.19.1.21141. eCollection 2016.

Introduction: It is unclear whether using peers can improve adherence to antiretroviral therapy (ART). To construct the World Health Organization's global guidance on adherence interventions, we conducted a systematic review and network meta-analysis to determine the effectiveness of using peers for achieving adequate adherence and viral suppression.

Methods: We searched for randomized clinical trials of peer-based interventions to promote adherence to ART in HIV populations. We searched six electronic databases from inception to July 2015 and major conference abstracts within the last three years. We examined the outcomes of adherence and viral suppression among trials done worldwide and those specific to low- and middle-income countries (LMIC) using pairwise and network meta-analyses.

Results and discussion: Twenty-two trials met the inclusion criteria. We found similar results between pairwise and network meta-analyses, and between the global and LMIC settings. Peer supporter+Telephone was superior in improving adherence than standard-of-care in both the global network (odds-ratio [OR]=4.79, 95% credible intervals [CrI]: 1.02, 23.57) and the LMIC settings (OR=4.83, 95% CrI: 1.88, 13.55). Peer support alone, however, did not lead to improvement in ART adherence in both settings. For viral suppression, we found no difference of effects among interventions due to limited trials.

Conclusions: Our analysis showed that peer support leads to modest improvement in adherence. These modest effects may be due to the fact that in many settings, particularly in LMICs, programmes already include peer supporters, adherence clubs and family disclosures for treatment support. Rather than introducing new interventions, a focus on improving the quality in the delivery of existing services may be a more practical and effective way to improve adherence to ART.

Abstract  Full-text [free] access 

Editor’s notes: Sustained adherence to antiretroviral therapy (ART) is critical to ensure successful treatment outcomes and prevent drug resistance, AIDS-associated illness, death and onward transmission of HIV infection. In recent years, there has been much enthusiasm for use of peer support as a programme to improve adherence. Most high HIV prevalence settings have limited resources. Stigma influences adherence to treatment, and peer-based support may be a practical solution both in terms of being low cost and a mechanism for addressing stigma.

In this systematic review, the authors evaluated the effectiveness of peer-supporter programmes alone or in combination with other activities, namely telephone calls, device reminders or cognitive behavioural therapy (CBT), globally and in low and middle-income countries (LMIC). The systematic review findings were used to inform the 2015 World Health Organization HIV treatment guidelines.

The study demonstrates that peer support alone did not have any impact on adherence or on viral suppression. It did demonstrate modest improvements on adherence when combined with telephone activities. Several factors need to be considered in interpreting these findings. Firstly, adherence was assessed using a variety of methods including pill counts and the Medication Event Monitoring System (MEMS), which may have introduced heterogeneity. Secondly, few trials (particularly in LMICs) used HIV viral load as an outcome and therefore there may not have been adequate statistical power to detect an effect. Thirdly, populations included in the review were heterogeneous e.g. ART-naïve and experienced, people who inject drugs, non-adherent individuals. Notably, only one trial included children and adolescents among whom adherence is typically poorer. 

Importantly, in many settings particularly in LMICs, programmes already include treatment supporters and adherence clubs and therefore additional peer support would likely not add additional impact. The findings of this study suggest that programmes should focus on improving the quality of existing services rather than introduce new programmes. The review also highlights the need to standardise adherence measures and the need for robust research on adherence, particularly among children.         

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Study finds rectal gel to be safe in men, but not as acceptable for daily use

MTN-017: a rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel.

Cranston RD, Lama JR, Richardson BA, Carballo-Dieguez A, Kunjara Na Ayudhya RP, Liu K, Patterson KB, Leu CS, Galaska B, Jacobson CE, Parikh UM, Marzinke MA, Hendrix CW, Johnson S, Piper JM, Grossman C, Ho KS, Lucas J, Pickett J, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Liu AY, Mayer KH, Zorrilla C, Schwartz JL, Rooney J, McGowan I; MTN-017 Protocol Team. Clin Infect Dis. 2016 Dec 16. pii: ciw832. [Epub ahead of print]

Background: HIV disproportionately affects men who have sex with men (MSM) and transgender women (TGW). Safe and acceptable topical HIV prevention methods that target the rectum are needed.

Methods: MTN-017 was a Phase 2, three-period, randomized sequence, open-label, expanded safety and acceptability crossover study comparing rectally applied reduced-glycerin (RG) 1% tenofovir (TFV) and oral emtricitabine/TFV disoproxil fumarate (FTC/TDF). In each 8-week study period participants were randomized to RG-TFV rectal gel daily; or RG-TFV rectal gel before and after receptive anal intercourse (RAI) (or at least twice weekly in the event of no RAI); or daily oral FTC/TDF.

Results: MSM and TGW (n=195) were enrolled from 8 sites in the United States, Thailand, Peru, and South Africa with mean age of 31.1 years (range 18-64). There were no differences in Grade 2 or higher adverse event rates in participants using daily gel (Incidence Rate Ratio (IRR): 1.09, p=0.59) or RAI gel (IRR: 0.90, p=0.51) compared to FTC/TDF. High adherence (≥80% of prescribed doses as assessed by unused product return and SMS reports) was less likely in the daily gel regimen (Odds Ratio (OR): 0.35, p<0.001) and participants reported less likelihood of future daily gel use for HIV protection compared to FTC/TDF (OR: 0.38, p<0.001).

Conclusions: Rectal application of RG TFV gel was safe in MSM and TGW. Adherence and product use likelihood were similar for the intermittent gel and daily oral FTC/TDF regimens, but lower for the daily gel regimen.

Abstract access  

Editor’s notes: While microbicide gel to prevent HIV in women has not been consistently shown to be effective, scientific efforts to develop a rectal microbicide gel have continued in the hopes of finding a safe and effective product for HIV prevention in men. This paper presents a phase II clinical trial in which gay men and other men who have sex with men across four different countries were randomly assigned to one of three arms: oral pre-exposure prophylaxis (‘daily oral’), topical gel administered before and after receptive anal intercourse (‘RAI’), and topical gel administered daily (‘daily rectal’). The authors found that the rectal gel was safe to use, and was acceptable to participants, although the daily rectal application had lower acceptability and lower adherence than daily oral or the RAI.  This safety, adherence, and acceptability seen in this Phase II study supports further development of the gel as a rectal microbicide candidate, although consideration will need to be given to dosing regimens to maximize adherence. 

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The Affordable Care Act at work – increasing health care access for people living with HIV in California

Implementation and operational research: affordable care act implementation in a California health care system leads to growth in HIV-positive patient enrollment and changes in patient characteristics.

Satre DD, Altschuler A, Parthasarathy S, Silverberg MJ, Volberding P, Campbell CI. J Acquir Immune Defic Syndr. 2016 Dec 15;73(5):e76-e82.

Objectives: This study examined implementation of the Affordable Care Act (ACA) in relation to HIV-positive patient enrollment in an integrated health care system; as well as changes in new enrollee characteristics, benefit structure, and health care utilization after key ACA provisions went into effect in 2014.

Methods: This mixed-methods study was set in Kaiser Permanente Northern California (KPNC). Qualitative interviews with 29 KPNC leaders explored planning for ACA implementation. Quantitative analyses compared newly enrolled HIV-positive patients in KPNC between January and December 2012 ("pre-ACA," N = 661) with newly enrolled HIV-positive patients between January and December 2014 ("post-ACA," N = 880) on demographics; medical, psychiatric, and substance use disorder diagnoses; HIV clinical indicators; and type of health care utilization.

Results: Interviews found that ACA preparation focused on enrollment growth, staffing, competition among health plans, concern about cost sharing, and HIV pre-exposure prophylaxis (PrEP) services. Quantitative analyses found that post-ACA HIV-positive patient enrollment grew. New enrollees in 2014 were more likely than 2012 enrollees to be enrolled in high-deductible plans (P < 0.01) or through Medicaid (P < 0.01), and marginally more likely to have better HIV viral control (P < 0.10). They also were more likely to be diagnosed with asthma (P < 0.01) or substance use disorders (P < 0.05) and to have used primary care health services in the 6 months postenrollment (P < 0.05) than the pre-ACA cohort.

Conclusions: As anticipated by KPNC interviewees, ACA implementation was followed by HIV-positive patient enrollment growth and changing benefit structures and patient characteristics. Although HIV viral control improved, comorbid diagnosis findings reinforced the importance of coordinated health care.

Abstract access  

Editor’s notes: This paper provides a very useful assessment of the Affordable Care Act (ACA) (commonly called ‘Obama-Care’) coverage for people living with HIV in part of California. As the authors note, a goal of the Affordable Care Act was to increase health-care coverage for people with chronic conditions. They also note that before the implementation of the ACA, many people living with HIV lacked health-care insurance covering HIV-medications and HIV medical care. It has the potential to make a difference to people with chronic conditions. The ACA has removed exclusions for insurance access, like pre-existing conditions. It has also removed caps on costs and provides financial support for health care premiums. 

As anticipated by the authors, the passing of the ACA had provided greater access to care for people living with HIV. However, challenges exist in supporting people living with HIV who have co-morbidities. The authors note that people living with HIV in need of psychiatric care, or because of substance use, were not always reached. This is partly because people do not come forward for care.  The authors suggest that integrated care where HIV-care is provided with support for other chronic conditions can help reach more people to come forward.

At a time of change in the United States, this paper is timely in highlighting the value of the Affordable Care Act for people living with HIV.  

Northern America
United States of America
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Improving ART adherence: what works?

Interventions to improve adherence to antiretroviral therapy: a systematic review and network meta-analysis.

Kanters S, Park JJ, Chan K, Socias ME, Ford N, Forrest JI, Thorlund K, Nachega JB, Mills EJ. Lancet HIV. 2017 Jan;4(1):e31-e40. doi: 10.1016/S2352-3018(16)30206-5. Epub 2016 Nov 16.

Background: High adherence to antiretroviral therapy is crucial to the success of HIV treatment. We evaluated comparative effectiveness of adherence interventions with the aim of informing the WHO's global guidance on interventions to increase adherence.

Methods: For this systematic review and network meta-analysis, we searched for randomised controlled trials of interventions that aimed to improve adherence to antiretroviral therapy regimens in populations with HIV. We searched Cochrane Central Register of Controlled Trials, Embase, and MEDLINE for reports published up to July 16, 2015, and searched major conference abstracts from Jan 1, 2013, to July 16, 2015. We extracted data from eligible studies for study characteristics, interventions, patients' characteristics at baseline, and outcomes for the study populations of interest. We used network meta-analyses to compare adherence and viral suppression for all study settings (global network) and for studies in low-income and middle-income countries only (LMIC network).

Findings: We obtained data from 85 trials with 16 271 participants. Short message service (SMS; text message) interventions were superior to standard of care in improving adherence in both the global network (odds ratio [OR] 1.48, 95% credible interval [CrI] 1.00-2.16) and in the LMIC network (1.49, 1.04-2.09). Multiple interventions showed generally superior adherence to single interventions, indicating additive effects. For viral suppression, only cognitive behavioural therapy (1.46, 1.05-2.12) and supporter interventions (1.28, 1.01-1.71) were superior to standard of care in the global network; none of the interventions improved viral response in the LMIC network. For the global network, the time discrepancy (whether the study outcome was measured during or after intervention was withdrawn) was an effect modifier for both adherence to antiretroviral therapy (coefficient estimate -0.43, 95% CrI -0.75 to -0.11) and viral suppression (-0.48; -0.84 to -0.12), suggesting that the effects of interventions wane over time.

Interpretation: Several interventions can improve adherence and viral suppression; generally, their estimated effects were modest and waned over time.

Abstract access  

Editor’s notes: Maintaining adherence to self-administered medications is difficult. On average, people who are prescribed medications for chronic diseases take fewer than half the prescribed doses. Evidence suggests that in most settings adherence to antiretroviral therapy (ART) is better than this, but there will always be people that struggle to maintain the high levels of adherence required for durable virologic suppression. In this analysis, there was some evidence that specific activities or combinations of activities improved virologic suppression. However, the effect sizes were small and when the analysis was confined to studies in low-income and middle-income countries, there was no evidence to suggest an effect on virologic suppression. Overall the evidence to support any particular activity or combination of activities was not compelling.     

Findings from this analysis have been incorporated into most recent consolidated ART guidelines from the World Health Organization. Trying to summarize complex evidence in this way creates many challenges. Trials were conducted in different populations. Some with all people starting ART, others with people considered to have high risk of suboptimal adherence, and others with people who already had adherence problems. The trials also naturally would have differed in content and quality of the usual package of care to support adherence (the comparator for most programme). 60% of the trials were conducted exclusively in the United States, while others were conducted across different settings.

These are just some of the things that make it difficult to synthesize this evidence into guidance that can be applicable to people living with HIV worldwide. HIV programmes in countries have to decide whether or not to adopt any of these activities that are recommended by WHO on the basis of relatively weak evidence. Would we expect activities aimed at improving adherence to be generalizable across different settings? One might argue probably not. Adherence is a multifactorial, dynamic process and there is unlikely to be a ‘one size fits all’ approach to supporting adherence. In the absence of better evidence for any specific activity, we should perhaps focus on improving the quality of the basic package of adherence support offered to all people receiving ART, while also developing better ways to identify when certain people might benefit from enhanced support.        

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Longitudinal HIV viral load measures give insights into disease burden and transmission risk in the USA

Durable viral suppression and transmission risk potential among persons with diagnosed HIV infection: United States, 2012-2013.

Crepaz N, Tang T, Marks G, Mugavero MJ, Espinoza L, Hall HI. Clin Infect Dis. 2016 Oct 1;63(7):976-83. doi: 10.1093/cid/ciw418. Epub 2016 Jun 29.

Background: We examined durable viral suppression, cumulative viral load (VL) burden, and transmission risk potential among human immunodeficiency virus (HIV)-diagnosed persons in care.

Methods: Using data from the National HIV Surveillance System from 17 jurisdictions with complete reporting of VL test results, we determined the percentage of persons in HIV care who achieved durable viral suppression (all VL results <200 copies/mL) and examined viremia copy-years and time spent above VL levels that increase the risk of HIV transmission during 2012-2013.

Results: Of 265 264 persons in HIV care in 2011, 238 641 had at least 2 VLs in 2012-2013. The median number of VLs per individual during the 2-year period was 5. Approximately 62% had durable viral suppression. The remaining 38% had high VL burden (geometric mean of viremia copy-years, 7261) and spent an average of 438 days, 316 days, and 215 days (60%, 43.2%, and 29.5% of the 2-year period) above 200, 1500, and 10 000 copies/mL. Women, blacks/African Americans, Hispanics/Latinos, persons with HIV infection attributed to transmission other than male-to-male sexual contact, younger age groups, and persons with gaps in care had higher viral burden and transmission risk potential.

Conclusions: Two-thirds of persons in HIV care had durable viral suppression during a 2-year period. One-third had high VL burden and spent substantial time above VL levels with increased risk of onward transmission. More intervention efforts are needed to improve retention in care and medication adherence so that more persons in HIV care achieve durable viral suppression.

Abstract access  

Editor’s notes: Virologic suppression is the ultimate goal of HIV care. It determines health outcomes and transmission risk. Most analyses assess viral suppression by considering a single viral load measure. However, adherence to antiretroviral therapy and engagement in HIV care are often not straightforward, but rather complex and dynamic. People living with HIV may transition in and out of treatment and care throughout their lifetime. Therefore, a single undetectable viral load may not equate to true virologic suppression in an individual, but rather only a snapshot. This has the potential for an inaccurate picture of HIV burden and transmission risk in a population.

Within this study, researchers used the longitudinal measures of durable viral suppression, viraemia copy years and time without viral load suppression to assess disease burden and HIV transmission risk in the United States of America. The analysis involved people ages 13 years or older diagnosed with HIV before 2011 and in care in one of 17 jurisdictions that reported complete CD4 and viral load data to the Centers for Disease Control and Prevention’s National HIV Surveillance System. Everyone had at least one viral load test in 2011 and at least two between 2012-2013, and all were alive at the end of 2013.

Of the 251 649 persons included, two thirds had durable viral suppression with all viral load values being <200 copies/mL over the two-year period. Of note, during the same time period an additional 20% (total 83%) of the cohort had a suppressed viral load on their latest test. This would have potentially underestimated disease burden if analysed in isolation. The remaining one-third, without durable viral suppression, had high plasma burden and spent substantial time without virologic suppression, increasing the risk of HIV transmission.  As would be expected, the percentages of persons with durable viral suppression were lower among people with gaps in care. Disparities in disease burden and transmission risk potential were seen in several other subgroups.

The use of longitudinal measures broadens insight into disease burden and transmission risk in this population. Of further interest would have been people that had no evidence of being in care in 2011 but had an unsuppressed viral load between 2012-13, thus contributing to the population disease burden. These people were unfortunately not included in the analyses but may increase overall population transmission risk over the two years.

The findings underscore the recognised need for focused care and treatment efforts to address these disparities in virologic suppression and improve retention in care in the United States of America. The study also encourages the use of longitudinal markers in informing public health planning and resource allocation.

Northern America
United States of America
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Improving programmes: a thematic synthesis of qualitative studies of treatment adherence programmes

Barriers and facilitators of interventions for improving antiretroviral therapy adherence: a systematic review of global qualitative evidence.

Ma Q, Tso LS, Rich ZC, Hall BJ, Beanland R, Li H, Lackey M, Hu F, Cai W, Doherty M, Tucker JD. J Int AIDS Soc. 2016 Oct 17;19(1):21166. doi: 10.7448/IAS.19.1.21166. eCollection 2016.

Introduction: Qualitative research on antiretroviral therapy (ART) adherence interventions can provide a deeper understanding of intervention facilitators and barriers. This systematic review aims to synthesize qualitative evidence of interventions for improving ART adherence and to inform patient-centred policymaking.

Methods: We searched 19 databases to identify studies presenting primary qualitative data on the experiences, attitudes and acceptability of interventions to improve ART adherence among PLHIV and treatment providers. We used thematic synthesis to synthesize qualitative evidence and the CERQual (Confidence in the Evidence from Reviews of Qualitative Research) approach to assess the confidence of review findings.

Results: Of 2982 references identified, a total of 31 studies from 17 countries were included. Twelve studies were conducted in high-income countries, 13 in middle-income countries and six in low-income countries. Study populations focused on adults living with HIV (21 studies, n=1025), children living with HIV (two studies, n=46), adolescents living with HIV (four studies, n=70) and pregnant women living with HIV (one study, n=79). Twenty-three studies examined PLHIV perspectives and 13 studies examined healthcare provider perspectives. We identified six themes related to types of interventions, including task shifting, education, mobile phone text messaging, directly observed therapy, medical professional outreach and complex interventions. We also identified five cross-cutting themes, including strengthening social relationships, ensuring confidentiality, empowerment of PLHIV, compensation and integrating religious beliefs into interventions. Our qualitative evidence suggests that strengthening PLHIV social relationships, PLHIV empowerment and developing culturally appropriate interventions may facilitate adherence interventions. Our study indicates that potential barriers are inadequate training and compensation for lay health workers and inadvertent disclosure of serostatus by participating in the intervention.

Conclusions: Our study evaluated adherence interventions based on qualitative data from PLHIV and health providers. The study underlines the importance of incorporating social and cultural factors into the design and implementation of interventions. Further qualitative research is needed to evaluate ART adherence interventions.

Abstract  Full-text [free] access 

Editor’s notes: This is a review of studies using qualitative methods to explore the experiences of people living with HIV and healthcare providers involved in programmes to support antiretroviral treatment adherence. The thematic synthesis is presented in two ways. First, the reviewed studies are categorised by types of adherence programmes, such as task shifting, education, or directly observed therapy. Secondly, the authors present themes that are common across all reviewed studies. These include: the benefits and challenges of employing lay healthcare workers; the need to maintain confidentiality in adherence programmes; the benefits of supporting empowerment and social relationships for people living with HIV; and the need for culturally appropriate information and practice. Overall the review illustrates that adherence programmes can have more impact if they address confidentiality, strengthen social ties among people living with HIV and their communities; provide adequate compensation and training for lay healthcare workers; and sensitively reflect local social, cultural and religious norms and beliefs. 

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Weekends off ART: a strategy to maintain adherence in children and adolescents?

Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents, and young adults (BREATHER): a randomised, open-label, non-inferiority, phase 2/3 trial.

The BREATHER (PENTA 16) Trial Group. Lancet HIV. 2016 Sep;3(9):e421-30. doi: 10.1016/S2352-3018(16)30054-6. Epub 2016 Jun 20.

Background: For HIV-1-infected young people facing lifelong antiretroviral therapy (ART), short cycle therapy with long-acting drugs offers potential for drug-free weekends, less toxicity, and better quality-of-life. We aimed to compare short cycle therapy (5 days on, 2 days off ART) versus continuous therapy (continuous ART).

Methods: In this open-label, non-inferiority trial (BREATHER), eligible participants were aged 8-24 years, were stable on first-line efavirenz with two nucleoside reverse transcriptase inhibitors, and had HIV-1 RNA viral load less than 50 copies per mL for 12 months or longer. Patients were randomly assigned (1:1) to remain on continuous therapy or change to short cycle therapy according to a computer-generated randomisation list, with permuted blocks of varying size, stratified by age and African versus non-African sites; the list was prepared by the trial statistician and randomisation was done via a web service accessed by site clinician or one of the three coordinating trials units. The primary outcome was the proportion of participants with confirmed viral load 50 copies per mL or higher at any time up to the 48 week assessment, estimated with the Kaplan-Meier method. The trial was powered to exclude a non-inferiority margin of 12%. Analyses were intention to treat. The trial was registered with EudraCT, number 2009-012947-40, ISRCTN, number 97755073, and CTA, number 27505/0005/001-0001.

Findings: Between April 1, 2011, and June 28, 2013, 199 participants from 11 countries worldwide were randomly assigned, 99 to the short cycle therapy and 100 to continuous therapy, and were followed up until the last patient reached 48 weeks. 105 (53%) were men, median age was 14 years (IQR 12-18), and median CD4 cell count was 735 cells per µL (IQR 576-968). Six percent (6%) patients assigned to the short cycle therapy versus seven percent (7%) assigned to continuous therapy had confirmed viral load 50 copies per mL or higher (difference -1.2%, 90% CI -7.3 to 4.9, non-inferiority shown). 13 grade 3 or 4 events occurred in the short cycle therapy group and 14 in the continuous therapy group (p=0.89). Two ART-related adverse events (one gynaecomastia and one spontaneous abortion) occurred in the short cycle therapy group compared with 14 (p=0.02) in the continuous therapy group (five lipodystrophy, two gynaecomastia, one suicidal ideation, one dizziness, one headache and syncope, one spontaneous abortion, one neutropenia, and two raised transaminases).

Interpretation: Non-inferiority of maintaining virological suppression in children, adolescents, and young adults was shown for short cycle therapy versus continuous therapy at 48 weeks, with similar resistance and a better safety profile. This short cycle therapy strategy is a viable option for adherent HIV-infected young people who are stable on efavirenz-based ART.

Abstract  Full-text [free] access 

Editor’s notes: Increasing number of children born with HIV infection, who would otherwise have died in infancy, are now reaching adolescence because of the scale-up of antiretroviral therapy (ART). Adherence to treatment for chronic illnesses often drops as children approach adolescence, and unfortunately HIV is no exception.  

BREATHER is an open-label, non-inferiority trial comparing continuous daily ART (CT) with short cycle treatment (SCT) enabling two days off treatment every week. The participants were aged 8 to 24 years and had to have been virally suppressed for at least one year prior to enrolment on an ART regimen containing efavirenz. At 48 weeks, 6.1% of children in the SCT arm versus 7.3% in the CT arm had virologic rebound (defined as an HIV viral load > 50 copies/ml), demonstrating that SCT is non-inferior to CT. There was no statistical difference between arms in the proportion who developed major resistance mutations or in proportion of adverse events.

This is the first trial to demonstrate that controlled interruption appears to be safe in terms of maintaining viral suppression and lack of emergence of drug resistance mutations. Notably, the trial was conducted in geographically diverse settings (11 countries) and achieved an impressive retention rate with only one participant being lost to follow-up. In addition, the strategy was highly acceptable to participants, particularly as it provided a legitimate way of missing doses. Children are expected to take ART for 20 years longer on average than adults and strategies that enable time off ART may be an effective way to reduce treatment fatigue. In addition, reduced ART usage may provide potential cost savings. 

A concern, however, is that such a strategy may give out the detrimental message that missing doses is acceptable and may not affect the viral load. Therefore, appropriate counselling is important to ensure that people understand that there is a maximum break in treatment of two designated days per week. It is also important to note that the findings of this study are only generalisable to people who are stable on ART, who have not experienced treatment failure and who are taking efavirenz-based regimens. The trial was carried out with intensive viral load monitoring and further research is required to work out how such a strategy could be safely implemented in settings where routine viral load monitoring may not be available.

Viral suppression is the ultimate goal to improve health outcomes and reduce HIV transmission. Consistent adherence to ART is critical to ensure sustained virologic suppression. Children and adolescents face multiple challenges to adhere to treatment and a number of different approaches to address this are required- this trial now provides an innovative and promising option to offer to children.

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Improving retention in HIV care

Barriers and facilitators to interventions improving retention in HIV care: a qualitative evidence meta-synthesis.

Hall BJ, Sou KL, Beanland R, Lacky M, Tso LS, Ma Q, Doherty M, Tucker JD. AIDS Behav. 2016 Aug 31. [Epub ahead of print]

Retention in HIV care is vital to the HIV care continuum. The current review aimed to synthesize qualitative research to identify facilitators and barriers to HIV retention in care interventions. A qualitative evidence meta-synthesis utilizing thematic analysis. Prospective review registration was made in PROSPERO and review procedures adhered to PRISMA guidelines. Nineteen databases were searched to identify qualitative research conducted with individuals living with HIV and their caregivers. Quality assessment was conducted using CASP and the certainty of the evidence was evaluated using CERQual. A total of 4419 citations were evaluated and 11 were included in the final meta-synthesis. Two studies were from high-income countries, 3 from middle-income countries, and 6 from low-income countries. A total of eight themes were identified as facilitators or barriers for retention in HIV care intervention: (1) stigma and discrimination, (2) fear of HIV status disclosure, (3) task shifting to lay health workers, (4) human resource and institutional challenges, (5) mobile health (mHealth), (6) family and friend support, (7) intensive case management, and, (8) relationships with caregivers. The current review suggests that task shifting interventions with lay health workers were feasible and acceptable. mHealth interventions and stigma reduction interventions appear to be promising interventions aimed at improving retention in HIV care. Future studies should focus on improving the evidence base for these interventions. Additional research is needed among women and adolescents who were under-represented in retention interventions.

Abstract access 

Editor’s notes: Retention in HIV care is defined as the continued engagement in health services from enrolment in care to discharge or death of an individual living with HIV. There is strong evidence for the clinical and public health benefits of early antiretroviral therapy initiation. Individuals retained in care have lower mortality and a higher likelihood of viral suppression. Universal test and treat strategies are dependent on successful retention in HIV care.

A qualitative evidence meta-synthesis utilising thematic analysis was conducted. Some 11 studies were ultimately included in the review. Task shifting to non-specialist community caregivers was the most common activity identified in the review. Other programmes included home-based care, case management, primary HIV medical care, counselling, and mHealth.

The findings of the meta-synthesis highlight eight themes that were identified as facilitators or barriers for retention in HIV care programmes. This offers important insights for improving retention in care. However, more research is necessary to understand the experience of important sub populations including pregnant women, children and adolescents and key populations including gay men and other men who have sex with men.  The authors also emphasise the need for studies to provide particular emphasis on the perspectives of individuals living with HIV and providers involved in programme delivery. This, they argue, would greatly enhance subsequent implementation and development of tailored programmes to retain individuals living with HIV in care.

Africa, Northern America
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Violence and HIV among poor urban women in the USA

Physical and sexual violence predictors: 20 years of the women's interagency HIV study cohort.

Decker MR, Benning L, Weber KM, Sherman SG, Adedimeji A, Wilson TE, Cohen J, Plankey MW, Cohen MH, Golub ET. Am J Prev Med. 2016 Nov;51(5):731-742. pii: S0749-3797(16)30253-7. doi: 10.1016/j.amepre.2016.07.005. [Epub 2016 Aug 29]. 

Introduction: Gender-based violence (GBV) threatens women's health and safety. Few prospective studies examine physical and sexual violence predictors. Baseline/index GBV history and polyvictimization (intimate partner violence, non-partner sexual assault, and childhood sexual abuse) were characterized. Predictors of physical and sexual violence were evaluated over follow-up.

Methods: HIV-infected and uninfected participants (n=2838) in the Women's Interagency HIV Study provided GBV history; 2669 participants contributed 26 363 person years of follow-up from 1994 to 2014. In 2015-2016, multivariate log-binomial/Poisson regression models examined violence predictors, including GBV history, substance use, HIV status, and transactional sex.

Results: Overall, 61% reported index GBV history; over follow-up, 10% reported sexual and 21% reported physical violence. Having experienced all three forms of past GBV posed the greatest risk (adjusted incidence rate ratio [AIRR]physical=2.23, 95% CI=1.57, 3.19; AIRRsexual=3.17, 95% CI=1.89, 5.31). Time-varying risk factors included recent transactional sex (AIRRphysical=1.29, 95% CI=1.03, 1.61; AIRRsexual=2.98, 95% CI=2.12, 4.19), low income (AIRRphysical=1.22, 95% CI=1.01, 1.45; AIRRsexual=1.38, 95% CI=1.03, 1.85), and marijuana use (AIRRphysical=1.43, 95% CI=1.22, 1.68; AIRRsexual=1.57, 95% CI=1.19, 2.08). For physical violence, time-varying risk factors additionally included housing instability (AIRR=1.37, 95% CI=1.15, 1.62); unemployment (AIRR=1.38, 95% CI=1.14, 1.67); exceeding seven drinks/week (AIRR=1.44, 95% CI=1.21, 1.71); and use of crack, cocaine, or heroin (AIRR=1.76, 95% CI=1.46, 2.11).

Conclusions: Urban women living with HIV and their uninfected counterparts face sustained GBV risk. Past experiences of violence create sustained risk. Trauma-informed care, and addressing polyvictimization, structural inequality, transactional sex, and substance use treatment, can improve women's safety.

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Editor’s notes: Gender-based violence results in physical, sexual and mental health morbidities, including HIV risk behaviours and HIV infection. There is limited prospective research on risk factors for physical and sexual violence. This study characterised leading violence forms – that is, intimate partner violence, non-partner sexual assault and childhood sexual assault – among a cohort of low-income women living in six American cities, some of whom are living with HIV. It also examined predictors of violence experience during follow-up. This study found extensive gender-based violence of all types, listed above, among this cohort of 2838 HIV positive and HIV negative women. Lifetime gender-based violence history was highly prevalent among white women (72%), non-heterosexual women (74%), homeless / unstably housed women (80%) and among women with a sex work history (81%). Experience of different types of gender-based violence by baseline conferred significant risk for subsequent physical and sexual violence. HIV status did not confer risk for violence victimisation indicating that low-income women in this setting are at considerable risk for violence, regardless of their HIV status.

This study presents data from the largest ongoing prospective cohort study among American women living with HIV and includes a demographically matched HIV negative comparison group. The key limitation of this study was the non-probability sample, which limits generalisability of these results. The results are best generalised to urban American women in high-HIV prevalence settings. Additional cohort studies are necessary in other settings and contexts. However, the findings demonstrate the need to understand and address different forms of violence experienced by the same woman for violence prevention and health promotion. They support the USA 2015 National HIV/AIDS strategy recommendations to address violence and trauma for women both at risk for and living with HIV. 

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Treating depression and boosting adherence together

Cognitive behavioural therapy for adherence and depression in patients with HIV: a three-arm randomised controlled trial.

Safren SA, Bedoya CA, O'Cleirigh C, Biello KB, Pinkston MM, Stein MD, Traeger L, Kojic E, Robbins GK, Lerner JA, Herman DS, Mimiaga MJ, Mayer KH. Lancet HIV. 2016 Nov;3(11):e529-e538. pii: S2352-3018(16)30053-4. doi: 10.1016/S2352-3018(16)30053-4. [Epub 2016 Sep 19]

Background: Depression is highly prevalent in people with HIV and has consistently been associated with poor antiretroviral therapy (ART) adherence. Integrating cognitive behavioural therapy (CBT) for depression with adherence counselling using the Life-Steps approach (CBT-AD) has an emerging evidence base. The aim of this study was to test the efficacy of CBT-AD.

Methods: In this three-arm randomised controlled trial in HIV-positive adults with depression, we compared CBT-AD with information and supportive psychotherapy plus adherence counselling using the Life-Steps approach (ISP-AD), and with enhanced treatment as usual (ETAU) including Life-Steps adherence counselling only. Participants were recruited from three sites in New England, USA (two hospital settings and one community health centre). Patients were randomly assigned (2:2:1) to receive CBT-AD (one Life-Steps session plus 11 weekly integrated sessions lasting up to 1 h each), ISP-AD (one Life-Steps session plus 11 weekly integrated sessions lasting up to 1 h each), or ETAU (one Life-Steps session and five assessment visits roughly every 2 weeks), randomisation was done with allocation software, in pairs, and stratified by three variables: study site, whether or not participants had been prescribed antidepressant medication, and whether or not participants had a history of injection drug use. The primary outcome was ART adherence at the end of treatment (4 month assessment) assessed via electronic pill caps (Medication Event Monitoring System [MEMS]) with correction for pocketed doses, analysed by intention to treat.

Findings: Patients were recruited from Feb 26, 2009, to June 21, 2012. Patients who were assigned to CBT-AD (94 randomly assigned, 83 completed assessment) had greater improvements in adherence (estimated difference 1.00 percentage point per visit, 95% CI 0.34 to 1.66, p=0.003) and depression (Center for Epidemiological Studies depression [CESD] score estimated difference -0.41, -0.66 to -0.16, p=0.001; Montgomery-Asberg depression rating scale [MADRS] score -4.69, -8.09 to -1.28, p=0.007; clinical global impression [CGI] score -0.66, -1.11 to -0.21, p=0.005) than did patients who had ETAU (49 assigned, 46 completed assessment) after treatment (4 months). No significant differences in adherence were noted between CBT-AD and ISP-AD (97 assigned, 87 completed assessment). No study-related adverse events were reported.

Interpretation: Integrating evidenced-based treatment for depression with evidenced-based adherence counselling is helpful for individuals living with HIV/AIDS and depression. Future efforts should examine how to best disseminate effective psychosocial depression treatments such as CBT-AD to people living with HIV/AIDS and examine the cost-effectiveness of such approaches.

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Editor’s notes: Clinical depression is highly prevalent in people living with HIV, and common symptoms of depression (such as poor attention and negative thinking) can lead to poor adherence to ART. There is an emerging evidence base that integrating cognitive behaviour therapy (CBT) for adherence with CBT for depression may improve ART adherence, but this is based on relatively few, small, studies. This paper presents results of a full-scale three-arm efficacy trial to evaluate a CBT-based programme on HIV outcomes among people living with HIV with comorbid depression (CBT-AD) compared with a time-matched information and supportive psychotherapy activity with adherence counselling (ISP-AD), and enhanced treatment as usual.  The CBT-AD programme is based on the Life-Steps adherence counselling programme - a problem-solving approach to help people identify behavioural changes they can make to improve adherence. For both adherence (assessed using electronic pill caps) and depression, CBT-AD performed better than enhanced usual care over the four month treatment period and an eight month follow-up period, but was no better than ISP-AD. However, there was no effect on viral load or the proportion with detectable viral load, the end result of adherence. This may be because 90% of participants had viral suppression at baseline so there was a ceiling effect on improvement, because the increase in adherence may not have been sufficient to reach undetectable viral load or due to problems with measurement errors of adherence. This trial illustrates that psychosocial therapy for ART adherence has potential to improve adherence among people living with HIV. But further studies are necessary – including in LMIC, and restricting participants to people who are not virologically supressed. 

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United States of America
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