Articles tagged as "People living with HIV"

Near elimination of HIV transmission with combined ART and PrEP

Integrated delivery of antiretroviral treatment and pre-exposure prophylaxis to HIV-1-serodiscordant couples: a prospective implementation study in Kenya and Uganda.

Baeten JM, Heffron R, Kidoguchi L, Mugo NR, Katabira E, Bukusi EA, Asiimwe S, Haberer JE, Morton J, Ngure K, Bulya N, Odoyo J, Tindimwebwa E, Hendrix C, Marzinke MA, Ware NC, Wyatt MA, Morrison S, Haugen H, Mujugira A, Donnell D, Celum C. PLoS Med. 2016 Aug 23;13(8):e1002099. doi: 10.1371/journal.pmed.1002099. eCollection 2016.

Background: Antiretroviral-based interventions for HIV-1 prevention, including antiretroviral therapy (ART) to reduce the infectiousness of HIV-1 infected persons and pre-exposure prophylaxis (PrEP) to reduce the susceptibility of HIV-1 uninfected persons, showed high efficacy for HIV-1 protection in randomized clinical trials. We conducted a prospective implementation study to understand the feasibility and effectiveness of these interventions in delivery settings.

Methods and findings: Between November 5, 2012, and January 5, 2015, we enrolled and followed 1013 heterosexual HIV-1-serodiscordant couples in Kenya and Uganda in a prospective implementation study. ART and PrEP were offered through a pragmatic strategy, with ART promoted for all couples and PrEP offered until 6 mo after ART initiation by the HIV-1 infected partner, permitting time to achieve virologic suppression. One thousand thirteen couples were enrolled, 78% of partnerships initiated ART, and 97% used PrEP, during a median follow-up of 0.9 years. Objective measures of adherence to both prevention strategies demonstrated high use (≥85%). Given the low HIV-1 incidence observed in the study, an additional analysis was added to compare observed incidence to incidence estimated under a simulated counterfactual model constructed using data from a prior prospective study of HIV-1-serodiscordant couples. Counterfactual simulations predicted 39.7 HIV-1 infections would be expected in the population at an incidence of 5.2 per 100 person-years (95% CI 3.7-6.9). However, only two incident HIV-1 infections were observed, at an incidence of 0.2 per 100 person-years (95% CI 0.0-0.9, p < 0.0001 versus predicted). The use of a non-concurrent comparison of HIV-1 incidence is a potential limitation of this approach; however, it would not have been ethical to enroll a contemporaneous population not provided access to ART and PrEP.

Conclusions: Integrated delivery of time-limited PrEP until sustained ART use in African HIV-1-serodiscordant couples was feasible, demonstrated high uptake and adherence, and resulted in near elimination of HIV-1 transmission, with an observed HIV incidence of <0.5% per year compared to an expected incidence of >5% per year.

Abstract  Full-text [free] access 

Editor’s notes: Long-term follow-up of the landmark HPTN-052 trial of ART for prevention of HIV transmission between HIV serodiscordant couples was covered in a recent issue of HIV This Month. In that trial, of the few transmission events that did occur, half were during the first few months of ART use in the HIV-positive partner, before viral load suppression. This study from Kenya and Uganda now suggests that offering pre-exposure prophylaxis (PrEP) to the HIV-negative partner to bridge the gap until virologic suppression may be an effective way to almost eliminate the risk of transmission.

In this study there were significant delays in ART initiation in the HIV-positive partner. At the start of the study the recommendation for ART initiation was a CD4+ cell count <350, and only half of the HIV-positive partners had initiated ART by six months. PrEP uptake by the HIV-negative partner was high during this time period and high levels of adherence were sustained, suggesting that this was a feasible and acceptable strategy for discordant couples.

The activities were delivered using specific clinical research facilities and staff, so the logical next step would be to demonstrate scalability with delivery through routine health systems and through more innovative community-based systems.  

Africa
Kenya, Uganda
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Pregnancy and intimate partner violence among women living with HIV

Intimate partner violence experienced by HIV-infected pregnant women in South Africa: a cross-sectional study.

Bernstein M, Phillips T, Zerbe A, McIntyre JA, Brittain K, Petro G, Abrams EJ, Myer L. BMJ Open. 2016 Aug 16;6(8):e011999. doi: 10.1136/bmjopen-2016-011999.

Objectives: Intimate partner violence (IPV) during pregnancy may be common in settings where HIV is prevalent but there are few data on IPV in populations of HIV-infected pregnant women in Southern Africa. We examined the prevalence and correlates of IPV among HIV-infected pregnant women.

Setting: A primary care antenatal clinic in Cape Town, South Africa.

Participants: 623 consecutive HIV-infected pregnant women initiating lifelong antiretroviral therapy.

Measures: IPV, depression, substance use and psychological distress were assessed using the 13-item WHO Violence Against Women questionnaire, the Edinburgh Postnatal Depression Scale (EPDS), Alcohol and Drug Use Disorders Identification Tests (AUDIT/DUDIT) and the Kessler 10 (K-10) scale, respectively.

Results: The median age in the sample was 28 years, 97% of women reported being in a relationship, and 70% of women reported not discussing and/or agreeing on pregnancy intentions before conception. 21% of women (n=132) reported experiencing ≥1 act of IPV in the past 12 months, including emotional (15%), physical (15%) and sexual violence (2%). Of those reporting any IPV (n=132), 48% reported experiencing 2 or more types. Emotional and physical violence was most prevalent among women aged 18-24 years, while sexual violence was most commonly reported among women aged 25-29 years. Reported IPV was less likely among married women, and women who experienced IPV were more likely to score above threshold for substance use, depression and psychological distress. In addition, women who reported not discussing and/or not agreeing on pregnancy intentions with their partner prior to conception were significantly more likely to experience violence.

Conclusions: HIV-infected pregnant women in the study reported experiencing multiple forms of IPV. While the impact of IPV on maternal and child health outcomes in the context of HIV infection requires further research attention, IPV screening and support services should be considered within the package of routine care for HIV-infected pregnant women.

Trial registration number: NCT01933477.

Abstract  Full-text [free] access 

Editor’s notes: Intimate partner violence among women in sub-Saharan Africa is >30%. There is limited research examining intimate partner violence among women living with HIV. Research is important as intimate partner violence may impact on a woman’s ability to adhere to antiretroviral therapy. Among pregnant women, this includes during pregnancy and post-partum. This study describes the prevalence of recent intimate partner violence, and examines associations between recent intimate partner violence and demographic, relationship and psychological variables.

The study was set in a township in Cape Town, South Africa, where the majority of residents have low socio-economic status and HIV infection among women is approximately 30%. Some 21% percent of 623 participants reported any recent intimate partner violence in the past 12 months.  Fifteen percent reported emotional violence, 15% physical violence (7% severe physical) and two percent sexual violence. Recent violence was associated with hazardous alcohol use, psychological distress and depression. It was more likely among unmarried women, and among women who had not discussed/agreed pregnancy prior to conception. There was no evidence to suggest intimate partner violence was elevated among women newly diagnosed with HIV.

These data suggest significant intimate partner violence experience among pregnant women living with HIV, living in this township. This study adds to the limited literature, examining intimate partner violence in the context of pregnancy and HIV. Longitudinal studies, and studies which examine the impact of intimate partner violence on ART uptake and adherence, including during pregnancy and post-partum, are necessary. 

Africa
South Africa
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‘Scared of going there’ – barriers to HIV treatment for pregnant women in Tanzania

Stigma, facility constraints, and personal disbelief: why women disengage from HIV care during and after pregnancy in Morogoro region, Tanzania.

McMahon SA, Kennedy CE, Winch PJ, Kombe M, Killewo J, Kilewo C. AIDS Behav. 2016 Aug 17. [Epub ahead of print]

Millions of children are living with HIV in sub-Saharan Africa, and the primary mode of these childhood infections is mother-to-child transmission. While existing interventions can virtually eliminate such transmission, in low- and middle-income settings, only 63% of pregnant women living with HIV accessed medicines necessary to prevent transmission. In Tanzania, HIV prevalence among pregnant women is 3.2%. Understanding why HIV-positive women disengage from care during and after pregnancy can inform efforts to reduce the impact of HIV on mothers and young children. Informed by the tenets of Grounded Theory, we conducted qualitative interviews with 40 seropositive postpartum women who had disengaged from care to prevent mother-to-child transmission (PMTCT). Nearly all women described antiretroviral treatment (ART) as ultimately beneficial but effectively inaccessible given concerns related to stigma. Many women also described how their feelings of health and vitality coupled with concerns about side effects underscored a desire to forgo ART until they deemed it immediately necessary. Relatively fewer women described not knowing or forgetting that they needed to continue their treatment regimens. We present a theory of PMTCT disengagement outlining primary and ancillary barriers. This study is among the first to examine disengagement by interviewing women who had actually discontinued care. We urge that a combination of intervention approaches such as mother-to-mother support groups, electronic medical records with same-day tracing, task shifting, and mobile technology be adapted, implemented, and evaluated within the Tanzanian setting.

Abstract access  

Editor’s notes: The push for universal access to antiretroviral therapy for everyone living with HIV faces many obstacles.  In many parts of the world, pregnant women are offered HIV testing as a part of antenatal care. Treatment is then offered if a woman is found to be HIV-positive. Many women accept this care, having been provided with the information that this is beneficial for their baby and also themselves. Some women who accept treatment take themselves out of care. This can be detrimental not only for the HIV status of their baby, but also for their general antenatal care. As the authors of this paper note, there is a growing body of literature that describes losses to care from the provider perspective. There are also a number of papers about women who have accepted care, who describe why others refuse treatment.  It is unusual to find detailed findings from interviews with women who have dropped out of or refused HIV treatment while pregnant. While the findings are not particularly surprising, the authors of this paper have captured the individual reasons why the 40 women interviewed in their study, left or never entered care. The reasons given underline the challenge of ‘prompt treatment’. Many women were not ready for immediate treatment.  Fears of the clinic layout ‘betraying’ a woman’s status are described. So too are the negative attitudes of health providers as well as family and community members. The authors provide an excellent example of how good qualitative research, conducted and analysed in an exemplary manner, offers valuable insights. This paper provides valuable information on an often hidden minority of women who are not ready or able ‘to test and treat’.

Africa
United Republic of Tanzania
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Young people living with HIV, stigma and its mental health effects

HIV-related stigma, shame, and avoidant coping: risk factors for internalizing symptoms among youth living with HIV?

Bennett DS, Hersh J, Herres J, Foster J. Child Psychiatry Hum Dev. 2016 Aug;47(4):657-64. doi: 10.1007/s10578-015-0599-y.

Youth living with HIV (YLH) are at elevated risk of internalizing symptoms, although there is substantial individual variability in adjustment. We examined perceived HIV-related stigma, shame-proneness, and avoidant coping as risk factors of internalizing symptoms among YLH. Participants (N = 88; ages 12-24) completed self-report measures of these potential risk factors and three domains of internalizing symptoms (depressive, anxiety, and PTSD) during a regularly scheduled HIV clinic visit. Hierarchical regressions were conducted for each internalizing symptoms domain, examining the effects of age, gender, and maternal education (step 1), HIV-related stigma (step 2), shame- and guilt-proneness (step 3), and avoidant coping (step 4). HIV-related stigma, shame-proneness, and avoidant coping were each correlated with greater depressive, anxiety, and PTSD symptoms. Specificity was observed in that shame-proneness, but not guilt-proneness, was associated with greater internalizing symptoms. In multivariable analyses, HIV-related stigma and shame-proneness were each related to greater depressive and PTSD symptoms. Controlling for the effects of HIV-related stigma and shame-proneness, avoidant coping was associated with PTSD symptoms. The current findings highlight the potential importance of HIV-related stigma, shame, and avoidant coping on the adjustment of YLH, as interventions addressing these risk factors could lead to decreased internalizing symptoms among YLH.

Abstract access

Editor’s notes: This study examined the relationship between stigma, shame and avoidant coping strategies and the development of internalizing symptoms, such as anxiety and depression, in young people living with HIV. It is based on researcher-administered questionnaires with 88 young people living with HIV attending an HIV clinic in Philadelphia, USA. The questionnaire included multiple scales to assess. These included young people’s self-reported issues with HIV stigma; tendency to feel shame; tendency to feel guilt; avoidant coping strategies; depressive symptoms; anxiety symptoms; and post-traumatic stress disorder symptoms. Multiple statistical analyses were performed, controlling for the effects of gender, age and maternal education. The study found that HIV-associated stigma, shame and avoidant strategies are risk-factors for the development of depression, anxiety and post-traumatic stress disorder in young people living with HIV. The study provides evidence for the development of psychosocial support that focuses on shame reduction as a way to mediate the impact of stigma on mental health outcomes for young people living with HIV.

Northern America
United States of America
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Real-world barriers to active TB case detection in HIV clinics

Implementation and operational research: use of symptom screening and sputum microscopy testing for active tuberculosis case detection among HIV-infected patients in real-world clinical practice in Uganda.

Roy M, Muyindike W, Vijayan T, Kanyesigye M, Bwana M, Wenger M, Martin J, Geng E. J Acquir Immune Defic Syndr. 2016 Aug 15;72(5):e86-91. doi: 10.1097/QAI.0000000000001067.

Background: The uptake of intensified active TB case-finding among HIV-infected patients using symptom screening is not well understood. We evaluated the rate and completeness of each interim step in the TB pulmonary "diagnostic cascade" to understand real-world barriers to active TB case detection.

Methods: We conducted a cohort analysis of new, antiretroviral therapy-naive, HIV-infected patients who attended a large HIV clinic in Mbarara, Uganda (March 1, 2012-September 30, 2013). We used medical records to extract date of completion of each step in the diagnostic cascade: symptom screen, order, collection, processing, and result. Factors associated with lack of sputum order were evaluated using multivariate Poisson regression and chart review of 50 screen-positive patients.

Results: Of 2613 patients, 2439 (93%) were screened for TB and 682 (28%) screened positive. Only 90 (13.2%) had a sputum order. Of this group, 83% completed the diagnostic cascade, 13% were diagnosed with TB, and 50% had a sputum result within 1 day of their visit. Sputum ordering was associated with WHO stage 3 or 4 HIV disease and greater number of symptoms. The main identifiable reasons for lack of sputum order in chart review were treatment of presumed malaria (51%) or bacterial infection (43%).

Conclusions: The majority of newly enrolled HIV-infected patients who screened positive for suspected TB did not have a sputum order, and those who did were more likely to have more symptoms and advanced HIV disease. Further evaluation of provider behavior in the management of screen-positive patients could improve active TB case detection rates.

Abstract access  

Editor’s notes: This cohort analysis of people enrolling for HIV care at a President’s Emergency Plan for AIDS Relief (PEPFAR) clinic in Uganda used medical record review to identify barriers to active TB case finding in a programmatic setting. This study is unique in evaluating each step along the entire TB diagnostic cascade, from the WHO screening tool, which asks about four symptoms, through to sputum result, in a setting where TB diagnosis was based on sputum microscopy, prior to availability of Xpert ® MTB/RIF.

The authors found high uptake of TB symptom screening at enrolment to HIV care, with cough being the most commonly reported symptom. However, most people with symptoms suggestive of TB were not documented to have had sputum investigation ordered, this being the major point of loss from the TB diagnostic pathway. Given that the prevalence of active TB among people newly testing HIV positive is consistently high in African countries, this represents a substantial missed opportunity for prompt identification and treatment of TB. The study design did not allow in-depth evaluation of the reasons for lack of sputum order since this may not be clearly documented in medical records. Factors such as a person’s inability to produce sputum should also be considered. Ultimately, a high sensitivity, affordable, non-sputum based, point-of-care diagnostic test for TB is necessary to overcome the barriers inherent in the current complex TB diagnostic pathway.

Africa
Uganda
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Antiretroviral therapy dramatically reduces transmission of HIV to sexual partners

Antiretroviral therapy for the prevention of HIV-1 transmission.

Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Cottle L, Zhang XC, Makhema J, Mills LA, Panchia R, Faesen S, Eron J, Gallant J, Havlir D, Swindells S, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano DD, Essex M, Hudelson SE, Redd AD, Fleming TR. N Engl J Med. 2016 Jul 18. [Epub ahead of print]

Background: An interim analysis of data from the HIV Prevention Trials Network (HPTN) 052 trial showed that antiretroviral therapy (ART) prevented more than 96% of genetically linked infections caused by human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. ART was then offered to all patients with HIV-1 infection (index participants). The study included more than 5 years of follow-up to assess the durability of such therapy for the prevention of HIV-1 transmission.

Methods: We randomly assigned 1763 index participants to receive either early or delayed ART. In the early-ART group, 886 participants started therapy at enrollment (CD4+ count, 350 to 550 cells per cubic millimeter). In the delayed-ART group, 877 participants started therapy after two consecutive CD4+ counts fell below 250 cells per cubic millimeter or if an illness indicative of the acquired immunodeficiency syndrome (i.e., an AIDS-defining illness) developed. The primary study end point was the diagnosis of genetically linked HIV-1 infection in the previously HIV-1-negative partner in an intention-to-treat analysis.

Results: Index participants were followed for 10,031 person-years; partners were followed for 8509 person-years. Among partners, 78 HIV-1 infections were observed during the trial (annual incidence, 0.9%; 95% confidence interval [CI], 0.7 to 1.1). Viral-linkage status was determined for 72 (92%) of the partner infections. Of these infections, 46 were linked (3 in the early-ART group and 43 in the delayed-ART group; incidence, 0.5%; 95% CI, 0.4 to 0.7) and 26 were unlinked (14 in the early-ART group and 12 in the delayed-ART group; incidence, 0.3%; 95% CI, 0.2 to 0.4). Early ART was associated with a 93% lower risk of linked partner infection than was delayed ART (hazard ratio, 0.07; 95% CI, 0.02 to 0.22). No linked infections were observed when HIV-1 infection was stably suppressed by ART in the index participant.

Conclusions: The early initiation of ART led to a sustained decrease in genetically linked HIV-1 infections in sexual partners. (Funded by the National Institute of Allergy and Infectious Diseases; HPTN 052 ClinicalTrials.gov number, NCT00074581.).

Abstract access

Editor’s notes: The HPTN 052 trial has been a landmark study in establishing antiretroviral therapy as a strategy for preventing onward transmission of HIV. It was a study of more than 800 couples. More than half of the couples were in African countries. In each couple, one sexual partner was HIV positive and the other HIV negative.  The participants living with HIV were randomised either to receive immediate antiretroviral therapy or to delay until their CD4 count fell to 350, an approved approach at that time. The HIV negative partners were then monitored for acquisition of HIV.  When new HIV infections occurred, the virus was studied for genetic similarity to the virus of the known positive partner. The interim analysis was published in 2011.  It illustrated the programme to be so effective that the randomisation was ended and all the participants living with HIV were offered antiretroviral therapy. 

This article presents data after five years of follow-up, and if anything the results are even more remarkable. In more than 10 000 person-years of follow up, there were only eight transmissions of genetically linked virus from participants receiving antiretroviral therapy. Of these transmissions, four occurred early in treatment when the viral load would not be expected to be suppressed.  The other four occurred after treatment failure. In this enormous study, there were therefore no linked transmissions from participants who were stable on treatment without detectable viraemia. The study provides powerful support for the UNAIDS 90-90-90 treatment target.  The widest possible effective use of antiretroviral therapy will not only improve the health of people treated but could have a dramatic effect on new HIV infections.

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Weekend breaks on efavirenz-based ART non-inferior in adolescents

BREATHER (PENTA 16) short-cycle therapy (SCT) (5 days on/2 days off) in young people with chronic human immunodeficiency virus infection: an open, randomised, parallel-group Phase II/III trial.

Butler K, Inshaw J, Ford D, Bernays S, Scott K, Kenny J, Klein N, Turkova A, Harper L, Nastouli E, Paparini S, Choudhury R, Rhodes T, Babiker A, Gibb D. Health Technol Assess. 2016 Jun;20(49):1-108. doi: 10.3310/hta20490.

Background: For human immunodeficiency virus (HIV)-infected adolescents facing lifelong antiretroviral therapy (ART), short-cycle therapy (SCT) with long-acting agents offers the potential for drug-free weekends, less toxicity, better adherence and cost savings.

Objectives: To determine whether or not efavirenz (EFV)-based ART in short cycles of 5 days on and 2 days off is as efficacious (in maintaining virological suppression) as continuous EFV-based ART (continuous therapy; CT). Secondary objectives included the occurrence of new clinical HIV events or death, changes in immunological status, emergence of HIV drug resistance, drug toxicity and changes in therapy.

Design: Open, randomised, non-inferiority trial.

Setting: Europe, Thailand, Uganda, Argentina and the USA.

Participants: Young people (aged 8-24 years) on EFV plus two nucleoside reverse transcriptase inhibitors and with a HIV-1 ribonucleic acid level [viral load (VL)] of < 50 copies/ml for > 12 months.

Interventions: Young people were randomised to continue daily ART (CT) or change to SCT (5 days on, 2 days off ART).

Main outcome measures: Follow-up was for a minimum of 48 weeks (0, 4 and 12 weeks and then 12-weekly visits). The primary outcome was the difference between arms in the proportion with VL > 50 copies/ml (confirmed) by 48 weeks, estimated using the Kaplan-Meier method (12% non-inferiority margin) adjusted for region and age.

Results: In total, 199 young people (11 countries) were randomised (n = 99 SCT group, n = 100 CT group) and followed for a median of 86 weeks. Overall, 53% were male; the median age was 14 years (21% ≥ 18 years); 13% were from the UK, 56% were black, 19% were Asian and 21% were Caucasian; and the median CD4% and CD4 count were 34% and 735 cells/mm3, respectively. By week 48, only one participant (CT) was lost to follow-up. The SCT arm had a 27% decreased drug exposure as measured by the adherence questionnaire and a MEMSCap Medication Event Monitoring System (MEMSCap Inc., Durham, NC, USA) substudy (median cap openings per week: SCT group, n = 5; CT group, n = 7). By 48 weeks, six participants in the SCT group and seven in the CT group had a confirmed VL > 50 copies/ml [difference -1.2%, 90% confidence interval (CI) -7.3% to 4.9%] and two in the SCT group and four in the CT group had a confirmed VL > 400 copies/ml (difference -2.1%, 90% CI -6.2% to 1.9%). All six participants in the SCT group with a VL > 50 copies/ml resumed daily ART, of whom five were resuppressed, three were on the same regimen and two with a switch; two others on SCT resumed daily ART for other reasons. Overall, three participants in the SCT group and nine in the CT group (p = 0.1) changed ART regimen, five because of toxicity, four for simplification reasons, two because of compliance issues and one because of VL failure. Seven young people (SCT group, n = 2; CT group, n = 5) had major non-nucleoside reverse transcriptase inhibitor mutations at VL failure, of whom two (n = 1 SCT group, n = 1 CT group) had the M184V mutation. Two young people had new Centers for Disease Control B events (SCT group, n = 1; CT group, n = 1). There were no significant differences between SCT and CT in grade 3/4 adverse events (13 vs. 14) or in serious adverse events (7 vs. 6); there were fewer ART-related adverse events in the SCT arm (2 vs. 14; p = 0.02). At week 48 there was no evidence that SCT led to increased inflammation using an extensive panel of markers. Young people expressed a strong preference for SCT in a qualitative substudy and in pre- and post-trial questionnaires. In total, 98% of the young people are taking part in a 2-year follow-up extension of the trial.

Conclusions: Non-inferiority of VL suppression in young people on EFV-based first-line ART with a VL of < 50 copies/ml was demonstrated for SCT compared with CT, with similar resistance, safety and inflammatory marker profiles. The SCT group had fewer ART-related adverse events. Further evaluation of the immunological and virological impact of SCT is ongoing. A limitation of the trial is that the results cannot be generalised to settings where VL monitoring is either not available or infrequent, nor to use of low-dose EFV. Two-year extended follow-up of the trial is ongoing to confirm the durability of the SCT strategy. Further trials of SCT in settings with infrequent VL monitoring and with other antiretroviral drugs such as tenofovir alafenamide, which has a long intracellular half-life, and/or dolutegravir, which has a higher barrier to resistance, are planned.

Trial registration: Current Controlled Trials ISRCTN97755073; EUDRACT 2009-012947-40; and CTA 27505/0005/001-0001.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (projects 08/53/25 and 11/136/108), the European Commission through EuroCoord (FP7/2007/2015), the Economic and Social Research Council, the PENTA Foundation, the Medical Research Council and INSERM SC10-US19, France, and will be published in full in Health Technology Assessment; Vol. 20, No. 49. See the NIHR Journals Library website for further project information.

Abstract  Full-text [free] access 

Editor’s notes: Adherence to ART has been shown to deteriorate in adolescence, with missed doses occurring particularly at weekends. Pharmacokinetic properties of some ART drugs, such as efavirenz, allow for a break in pill taking without a break in effective treatment. Non-inferiority trials evaluating five days on, two days off in adults have shown continuous ART to be non-inferior with low rates of virologic rebound.  This formed the rationale for this global, randomised Phase II/III trial in young people.

In the BREATHER trial, non-inferiority of viral suppression in adolescents on efavirenz-based first-line ART was shown for short-cycle treatment compared with continuous treatment. Overall 93% of adolescents remained virally suppressed. Findings from the two-year long-term follow-up phase will confirm if short-cycle treatment is effective and safe in this population.  Further studies are required to confirm the applicability of this strategy in real-life settings where viral load monitoring is likely to be less frequent than in a trial setting.

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Showing they care: lay-counsellors, home-based testing and the value of follow-up support

How home HIV testing and counselling with follow-up support achieves high testing coverage and linkage to treatment and prevention: a qualitative analysis from Uganda.

Ware NC, Wyatt MA, Asiimwe S, Turyamureeba B, Tumwesigye E, van Rooyen H, Barnabas RV, Celum CL. J Int AIDS Soc. 2016 Jun 28;19(1):20929. doi: 10.7448/IAS.19.1.20929. eCollection 2016.

Introduction: The successes of HIV treatment scale-up and the availability of new prevention tools have raised hopes that the epidemic can finally be controlled and ended. Reduction in HIV incidence and control of the epidemic requires high testing rates at population levels, followed by linkage to treatment or prevention. As effective linkage strategies are identified, it becomes important to understand how these strategies work. We use qualitative data from The Linkages Study, a recent community intervention trial of community-based testing with linkage interventions in sub-Saharan Africa, to show how lay counsellor home HIV testing and counselling (home HTC) with follow-up support leads to linkage to clinic-based HIV treatment and medical male circumcision services.

Methods: We conducted 99 semi-structured individual interviews with study participants and three focus groups with 16 lay counsellors in Kabwohe, Sheema District, Uganda. The participant sample included both HIV+ men and women (N=47) and HIV-uncircumcised men (N=52). Interview and focus group audio-recordings were translated and transcribed. Each transcript was summarized. The summaries were analyzed inductively to identify emergent themes. Thematic concepts were grouped to develop general constructs and framing propositional statements.

Results: Trial participants expressed interest in linking to clinic-based services at testing, but faced obstacles that eroded their initial enthusiasm. Follow-up support by lay counsellors intervened to restore interest and inspire action. Together, home HTC and follow-up support improved morale, created a desire to reciprocate, and provided reassurance that services were trustworthy. In different ways, these functions built links to the health service system. They worked to strengthen individuals' general sense of capability, while making the idea of accessing services more manageable and familiar, thus reducing linkage barriers.

Conclusions: Home HTC with follow-up support leads to linkage by building "social bridges," interpersonal connections established and developed through repeated face-to-face contact between counsellors and prospective users of HIV treatment and male circumcision services. Social bridges link communities to the service system, inspiring individuals to overcome obstacles and access care.

Abstract  Full-text [free] access 

Editor’s notes: How can people be encouraged once they have received a positive HIV-test result to link and stay in treatment? This is a crucial question as the momentum for everyone living with HIV to be on antiretroviral therapy grows.  The authors of this paper demonstrate clearly and succinctly the value of personal contact in supporting people to test and the link to care. Lay-counsellors paying visits to people’s homes provided the encouragement to help some people to link to care. The home visits were seen by people visited as a sign that ‘someone cared’.  The personal attention and information provided promoted trust. The visits also created a sense of obligation: the person visited felt they should do something in return to please the counsellor.

Increasing numbers of people living with HIV does not necessarily mean that it is easier for someone coping with a positive-test result to link to care. We should not underestimate the continued burden that an HIV-positive test result places on individuals.  Many barriers remain both to testing and sustaining a link to care. The authors of this paper provide examples of how to overcome some of those barriers. However, while this paper provides encouraging findings on the value of the home-based activity, the findings also pose a challenge. Can such follow-up support services, which demand more than a single visit, be provided widely enough to benefit all people who need such attention and support? 

Africa
Uganda
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Patient navigators and financial incentives have no effect on HIV viral suppression in people with substance use disorders

Effect of patient navigation with or without financial incentives on viral suppression among hospitalized patients with HIV infection and substance use: a randomized clinical trial.  

Metsch LR, Feaster DJ, Gooden L, Matheson T, Stitzer M, Das M, Jain MK, Rodriguez AE, Armstrong WS, Lucas GM, Nijhawan AE, Drainoni ML, Herrera P, Vergara-Rodriguez P, Jacobson JM, Mugavero MJ, Sullivan M, Daar ES, McMahon DK, Ferris DC, Lindblad R, VanVeldhuisen P, Oden N, Castellon PC, Tross S, Haynes LF, Douaihy A, Sorensen JL, Metzger DS, Mandler RN, Colfax GN, del Rio C. JAMA. 2016 Jul 12;316(2):156-70. doi: 10.1001/jama.2016.8914.

Importance: Substance use is a major driver of the HIV epidemic and is associated with poor HIV care outcomes. Patient navigation (care coordination with case management) and the use of financial incentives for achieving predetermined outcomes are interventions increasingly promoted to engage patients in substance use disorders treatment and HIV care, but there is little evidence for their efficacy in improving HIV-1 viral suppression rates.

Objective: To assess the effect of a structured patient navigation intervention with or without financial incentives to improve HIV-1 viral suppression rates among patients with elevated HIV-1 viral loads and substance use recruited as hospital inpatients.

Design, setting, and participants: From July 2012 through January 2014, 801 patients with HIV infection and substance use from 11 hospitals across the United States were randomly assigned to receive patient navigation alone (n = 266), patient navigation plus financial incentives (n = 271), or treatment as usual (n = 264). HIV-1 plasma viral load was measured at baseline and at 6 and 12 months.

Interventions: Patient navigation included up to 11 sessions of care coordination with case management and motivational interviewing techniques over 6 months. Financial incentives (up to $1160) were provided for achieving targeted behaviors aimed at reducing substance use, increasing engagement in HIV care, and improving HIV outcomes. Treatment as usual was the standard practice at each hospital for linking hospitalized patients to outpatient HIV care and substance use disorders treatment.

Main outcomes and measures: The primary outcome was HIV viral suppression (200 copies/mL) relative to viral nonsuppression or death at the 12-month follow-up.

Results: Of 801 patients randomized, 261 (32.6%) were women (mean [SD] age, 44.6 years [10.0 years]). There were no differences in rates of HIV viral suppression versus nonsuppression or death among the 3 groups at 12 months. Eighty-five of 249 patients (34.1%) in the usual-treatment group experienced treatment success compared with 89 of 249 patients (35.7%) in the navigation-only group for a treatment difference of 1.6% (95% CI, -6.8% to 10.0%; P = .80) and compared with 98 of 254 patients (38.6%) in the navigation-plus-incentives group for a treatment difference of 4.5% (95% CI -4.0% to 12.8%; P = .68). The treatment difference between the navigation-only and the navigation-plus-incentives group was -2.8% (95% CI, -11.3% to 5.6%; P = .68).

Conclusions and relevance: Among hospitalized patients with HIV infection and substance use, patient navigation with or without financial incentives did not have a beneficial effect on HIV viral suppression relative to nonsuppression or death at 12 months vs treatment as usual. These findings do not support these interventions in this setting. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01612169.

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Editor’s notes: Substance use in people living with HIV has consistently been shown to be associated with poor clinical outcomes. Within this population, management often requires a combination of treatment for both HIV and substance use disorders. It is evident that it is the poor engagement in one or both of these treatment approaches that contributes significantly to poor clinical outcomes. The author’s group aimed to fill a gap in current evidence and explore whether two activities, patient navigation and financial incentives, could potentially motivate engagement with both treatment approaches and ultimately improve HIV viral suppression.

This study tested, among people living with HIV in hospital,  with substance use disorders, six months of patient navigation alone (care co-ordination and case management), or six months of patient navigation alongside a financial incentive plan. While overall uptake and retention to the programme schedules were high, no differences in HIV-1 viral suppression rates (which were generally poor) or death by 12 months were noted.

One factor that must be highlighted is that the participation in actual substance use treatment programmes post hospital discharge was low across all groups (average 24.8%), primarily due to a lack of available services in the regions. It may be that the programme may have been more effective in a different population of people already established in substance use treatment programmes, or if treatment had been more easily accessible.

The study serves as a reminder that such key populations are extremely vulnerable with a number of comorbidities and competing priorities. While not supporting health care navigation or financial incentives in their defined setting, the study findings emphasise a need to develop and tailor, cost-effective activities to improve health outcomes in this group.

Northern America
United States of America
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The negative health impacts of HIV-associated stigma

Examining the associations between HIV-related stigma and health outcomes in people living with HIV/AIDS: a series of meta-analyses.

Rueda S, Mitra S, Chen S, Gogolishvili D, Globerman J, Chambers L, Wilson M, Logie CH, Shi Q, Morassaei S, Rourke SB. BMJ Open. 2016 Jul 13;6(7):e011453. doi: 10.1136/bmjopen-2016-011453.

Objective: To conduct a systematic review and series of meta-analyses on the association between HIV-related stigma and health among people living with HIV.

Data sources: A structured search was conducted on 6 electronic databases for journal articles reporting associations between HIV-related stigma and health-related outcomes published between 1996 and 2013.

Study eligibility criteria: Controlled studies, cohort studies, case-control studies and cross-sectional studies in people living with HIV were considered for inclusion.

Outcome measures: Mental health (depressive symptoms, emotional and mental distress, anxiety), quality of life, physical health, social support, adherence to antiretroviral therapy, access to and usage of health/social services and risk behaviours.

Results: 64 studies were included in our meta-analyses. We found significant associations between HIV-related stigma and higher rates of depression, lower social support and lower levels of adherence to antiretroviral medications and access to and usage of health and social services. Weaker relationships were observed between HIV-related stigma and anxiety, quality of life, physical health, emotional and mental distress and sexual risk practices. While risk of bias assessments revealed overall good quality related to how HIV stigma and health outcomes were measured on the included studies, high risk of bias among individual studies was observed in terms of appropriate control for potential confounders. Additional research should focus on elucidating the mechanisms behind the negative relationship between stigma and health to better inform interventions to reduce the impact of stigma on the health and well-being of people with HIV.

Conclusions: This systematic review and series of meta-analyses support the notion that HIV-related stigma has a detrimental impact on a variety of health-related outcomes in people with HIV. This review can inform the development of multifaceted, intersectoral interventions to reduce the impact of HIV-related stigma on the health and well-being of people living with HIV.

Abstract  Full-text [free] access 

Editor’s notes: There is a growing body of research documenting the negative impact of stigma and discrimination on the health of people living with HIV. Stigma is associated with poorer mental health, including emotional distress, depression and reduced psychological functioning. It has also been linked to intermediate health outcomes such as seeking healthcare and adherence to antiretroviral therapy. This paper reports a comprehensive systematic review and meta-analyses summarising the published evidence on the relationship between HIV-associated stigma and a wide range of health outcomes, including intermediate health outcomes. Results illustrate associations between HIV-associated stigma and depressive symptoms, lower levels of social support, ART adherence and use of health services. However, the majority of studies in the review were cross-sectional and longitudinal studies are necessary to explore the complex relationship between these factors, including the role of moderating factors, such as coping strategies. In addition, more research is necessary from low- and middle-income countries given that much of the published research is from North America. Further, there is also a need to better understand the intersection of HIV-associated stigma with other types of stigma experienced by people living with HIV, including homophobia, racism and gender discrimination. 

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