Articles tagged as "People living with HIV"

No evidence of an increased risk of female-male HIV transmission with hormonal contraception in Zambia

Hormonal contraceptive use among HIV-positive women and HIV transmission risk to male partners, Zambia, 1994-2012.

Wall KM, Kilembe W, Vwalika B, Ravindhran P, Khu NH, Brill I, Chomba E, Johnson BA, Haddad LB, Tichacek A, Allen S. J Infect Dis. 2016 Oct 1;214(7):1063-71. doi: 10.1093/infdis/jiw322. Epub 2016 Jul 26.

Background: Evidence on the association between female-to-male human immunodeficiency virus (HIV) transmission risk and hormonal contraception is sparse and conflicting.

Methods: Heterosexual HIV-discordant couples from Lusaka, Zambia, were followed longitudinally at 3 month-intervals from 1994 to 2012. The impact of hormonal contraception on time to HIV transmission from HIV-positive women to their HIV-negative male partners (M-F+) was evaluated.

Results: Among 1601 M-F+ couples, 171 genetically linked HIV transmissions occurred in men over 3216 couple-years (5.3 transmissions/100 couple-years; 95% confidence interval [CI], 4.5-6.2). In multivariable Cox models, neither injectable (adjusted hazard ratio [aHR], 0.6; 95% CI, .4-1.2), oral contraceptive pill (aHR, 0.8; 95% CI, .3-2.1), nor implant (aHR, 0.8; 95% CI, .5-1.4) use was associated with HIV transmission, relative to nonhormonal methods, after controlling for the man's age at baseline and time-varying measures of pregnancy, self-reported unprotected sex with the study partner, sperm present on a vaginal swab wet mount, genital inflammation of either partner, genital ulceration of the man, and first follow-up interval. Sensitivity analyses, including marginal structural modeling and controlling for viral load and fertility intentions available in a subset of couples, led to similar conclusions.

Conclusions: Our findings suggest null associations between hormonal contraception and risk of female-to-male HIV transmission. We support efforts to increase the contraceptive method mix for all women, regardless of HIV serostatus, along with reinforced condom counseling for HIV-serodiscordant couples.

Abstract  Full-text [free] access 

Editor’s notes: Evidence suggests that certain injectable hormonal contraceptives (particularly depot medroxyprogesterone acetate [DMPA]) may increase HIV risk in women. However, few studies have assessed whether hormonal contraception increases the risk of female-male transmission. This paper presents results from an 18-year prospective follow-up study in Zambia. In the study, the investigators were able to analyse biologically linked results of serodiscordant couples and multiple methods of contraception. Their findings suggest no evidence of an increased risk of HIV transmission from women living with HIV to their male partners. In fact, couples with a linked transmission were less likely to use injectable contraceptives than women using non-hormonal methods (not statistically significant). This is encouraging; however, there are potential confounding factors in this study, such as high circumcision rates among men and low viral loads among women. The results also conflict with two earlier studies that found an increased risk of female-male transmission associated with hormonal contraception. More research is therefore necessary to provide evidence on this topic and enable recommendations on the use of hormonal contraception among serodiscordant couples.

Africa
Zambia
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A one-stop shop for HIV and non-communicable disease care in Kibera, Kenya

They just come, pick and go. The acceptability of integrated medication adherence clubs for HIV and non-communicable disease (NCD) patients in Kibera, Kenya.

Venables E, Edwards JK, Baert S, Etienne W, Khabala K, Bygrave H. AIDS Behav. 2016 Oct;20(10):2464-76. doi: 10.1007/s10461-016-1331-z.

Introduction: The number of people on antiretroviral therapy (ART) for the long-term management of HIV in low- and middle-income countries (LMICs) is continuing to increase, along with the prevalence of non-communicable diseases (NCDs). The need to provide large volumes of HIV patients with ART has led to significant adaptations in how medication is delivered, but access to NCD care remains limited in many contexts. Medication Adherence Clubs (MACs) were established in Kibera, Kenya to address the large numbers of patients requiring chronic HIV and/or NCD care. Stable NCD and HIV patients can now collect their chronic medication every three months through a club, rather than through individual clinic appointments.

Methodology: We conducted a qualitative research study to assess patient and health-care worker perceptions and experiences of MACs in the urban informal settlement of Kibera, Kenya. A total of 106 patients (with HIV and/or other NCDs) and health-care workers were purposively sampled and included in the study. Ten focus groups and 19 in-depth interviews were conducted and 15 sessions of participant observation were carried out at the clinic where the MACs took place. Thematic data analysis was conducted using NVivo software, and coding focussed on people's experiences of MACs, the challenges they faced and their perceptions about models of care for chronic conditions.

Results: MACs were considered acceptable to patients and health-care workers because they saved time, prevented unnecessary queues in the clinic and provided people with health education and group support whilst they collected their medication. Some patients and health-care workers felt that MACs reduced stigma for HIV positive patients by treating HIV as any other chronic condition. Staff and patients reported challenges recruiting patients into MACs, including patients not fully understanding the eligibility criteria for the clubs. There were also some practical challenges during the implementation of the clubs, but MACs have shown that it is possible to learn from ART provision and enable stable HIV and NCD patients to collect chronic medication together in a group.

Conclusions: Extending models of care previously only offered to HIV-positive cohorts to NCD patients can help to de-stigmatise HIV, allow for the efficient clinical management of co-morbidities and enable patients to benefit from peer support. Through MACs, we have demonstrated that an integrated approach to providing medication for chronic diseases including HIV can be implemented in resource-poor settings and could thus be rolled out in other similar contexts.

Abstract  Full-text [free] access 

Editor’s notes: As people living with HIV grow older, the chances of multi-morbidities increase. The number of non-communicable disease diagnosis is increasing generally in sub-Saharan Africa. This is not only because of changing lifestyles but also because of better diagnostic skills and ageing populations. The authors of this paper provide valuable information on how HIV and non-communicable disease care can be combined through the provision of ‘adherence clubs’. The clubs in Kibera, Kenya, have practical benefits for people living with more than one condition. The clubs also, as the authors state, provide a way to counter stigma around HIV, because the ‘medication adherence club’ is not disease specific. That said, a very useful and interesting finding from this research was the difference in views between health care workers and patients. The health care workers were often more positive in their views about the impact on stigma, for example, than the patients. It is apparent that sustained promotion of the purpose of the clubs is required. This publicity is necessary not only to spread information about the purpose of the club, but also to ensure people understand who is eligible to attend. If that publicity is successful, and the clubs can be sustained, the provision of an integrated service is an important step forward in chronic disease care models.

Africa
Kenya
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It’s hard to tell: healthcare workers experiences of telling children of their HIV positive status.

Experiences with disclosure of HIV-positive status to the infected child: perspectives of healthcare providers in Dar es Salaam, Tanzania.

Sariah A, Rugemalila J, Somba M, Minja A, Makuchilo M, Tarimo E, Urassa D, Siril H. BMC Public Health. 2016 Oct 13;16(1):1083.

Background: The specific age to which an HIV infected child can be disclosed to is stipulated to begin between ages 4 and 6 years. It has also been documented that before disclosure of HIV positive status to the infected child. Health care providers should consider children's cognitive-developmental ability. However, observation and situation analysis show that, health care providers still feel uncomfortable disclosing the HIV positive status to the infected child. The aim of the study was to explore healthcare providers' experiences in disclosure of HIV-positive status to the infected child.

Methods: A qualitative study involving 20 health care providers who attend HIV-positive children was conducted in September, 2014 in Dar es Salaam, Tanzania. Participants were selected from ten HIV care and treatment clinics (CTC) by purposive sampling. An interview guide, translated into participants' national language (Kiswahili) was used during in-depth interviews. Sampling followed the principle of data saturation. The interviews focused on perspectives of health-care providers regarding their experience with paediatric HIV disclosure. Data from in-depth interviews were transcribed into text; data analysis followed qualitative content analysis.

Results: The results show how complex the process of disclosure to children living with HIV can be to healthcare providers. Confusion was noted among healthcare providers about their role and responsibility in the process of disclosing to the HIV infected child. This was reported to be largely due to unclear guidelines and lack of standardized training in paediatric HIV disclosure. Furthermore, healthcare providers were concerned about parental hesitancy to disclose early to the child due to lack of disclosure skills and fear of stigma. In order to improve the disclosure process in HIV infected children, healthcare providers recommended further standardized training on paediatric HIV disclosure with more emphasis on practical skills and inclusion of disclosure content that is age appropriate for children with HIV.

Discussion: The disclosure process was found to be a complex process. Perspectives regarding disclosure in children infected with HIV varied among healthcare providers in terms of their role in the process, clear national guidelines and appropriate standardized training for paediatric disclosure. Consistent with other studies, healthcare providers reported difficulties during disclosure because parents /guardians largely fear blame, social stigma, child's negative emotional reaction when disclosed to and have concerns about the child being too young and immature to understand the HIV condition.

Conclusions: In order to prevent inconsistencies during the disclosure process, it is important to have in place clear guidelines and standardized paediatric HIV disclosure training for healthcare providers. This would help improve their skills in paediatric disclosure, leading to positive health outcomes for children infected with HIV.

Abstract  Full-text [free] access 

Editor’s notes: This valuable paper explores the experiences of healthcare providers who are disclosing to children and young people living with HIV. It focusses on a clinical setting in a district of Dar es Salaam in the United Republic of Tanzania. The authors examine factors that hinder and facilitate the process of disclosing to children and young people living with HIV through interviews with healthcare workers. Disclosure is understood to be pivotal in supporting children and young people’s adaptation to the realities of living with HIV and in managing their treatment and care effectively. While this topic has been the subject of much policy and research attention, this paper presents valuable insights into how disclosure is practised in reality. The authors point to the gap between what is in the guidelines and healthcare workers’ ability to deliver these principles within the context of the clinic. They note that disclosure is often with parental resistance and/ or concern. Another significant feature hindering healthcare workers’ ability to follow the disclosure guidelines was their limited training on disclosure, as well as in some cases their limited awareness of the guidelines. The authors present a stark picture of the distance between what ‘should’ be being done and what ‘is’ being done. The primary conclusion the authors draw is the significant need for improved training for healthcare workers. The provision of such training across clinics would enable healthcare workers to respond to the various dynamics. For example, parental reticence and lack of support, which currently result in disclosure being delayed or being done ineffectively.  

Africa
United Republic of Tanzania
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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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She looks healthy so is she dangerous to me? Unintended consequences of HIV treatment through the eyes of men in the community

They are looking just the same: antiretroviral treatment as social danger in rural Malawi.

Kaler A, Angotti N, Ramaiya A. Soc Sci Med. 2016 Oct;167:71-8. doi: 10.1016/j.socscimed.2016.08. 023. Epub 2016 Aug 18.

Research on the social impact of ART pivots on questions of individual adherence and community acceptability of treatment programmes. In this paper we examine unexpected and unintended consequences of the scale-up of treatment in rural Malawi, using a unique dataset of more than 150 observational journals from three sites, spanning 2010 to 2013, focusing on men's everyday conversations. Through thematic content analysis, we explore the emerging perception that the widespread availability of ART constitutes a form of social danger, as treatment makes it difficult to tell who does or does not have AIDS. This ambiguity introduced through ART is interpreted as putting individuals at risk, because it is no longer possible to tell who might be infected - indeed, the sick now look healthier and "plumper" than the well. This ambivalence over the social impact of ART co-exists with individual demand for and appreciation of the benefits of treatment.

Abstract access  

Editor’s notes: Widespread uptake of lifelong antiretroviral therapy means that our focus on its impact on communities should no longer be on its novelty but its consequences. This is a really interesting qualitative paper which reflects on how men in a rural community in Malawi consider the social dangers that women who are on HIV treatment, specifically, pose to men. Through the content analysis of journal entries, which captured men’s informal conversations, the researchers draw out this sub group’s ambivalence towards antiretroviral therapy. Women who have HIV can become appealing sexual partners through projecting a healthy attractiveness. Thus treatment is portrayed as disruptive by putting men, attracted to plump/ healthy women, at risk. It is revealing that two of the key tenets of current prevention policy are relatively silent within these findings. Neither the message of the prevention benefits of treatment, in which people successfully adhering to treatment pose a minimal transmission risk, nor the message that sex should be protected, because anyone’s status should be considered unknown, appears to have a significant influence on either discourse or practice. By paying attention to the ‘hum’ and ‘chatter’ of everyday life we can learn about how treatment opportunities are interpreted. We can also gain insights into how they are understood in accordance with concerns around sexual opportunities and sexual appeal. These may change but they continue to be heavily shaped by gender.  

Africa
Malawi
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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.

Abstract access  

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. 

Northern America
United States of America
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The limits of HIV disclosure for women in 27 countries

The association between HIV disclosure status and perceived barriers to care faced by women living with HIV in Latin America, China, central/eastern Europe, and western Europe/Canada.

Loutfy M, Johnson M, Walmsley S, Samarina A, Vasquez P, Hao-Lan H, Madihlaba T, Martinez-Tristani M, van Wyk J. AIDS Patient Care STDS. 2016 Sep;30(9):435-44. doi: 10.1089/apc.2016.0049. Epub 2016 Aug 23.

Generally, women are less likely than men to disclose their HIV status. This analysis examined the relationship between HIV disclosure and (1) perceived barriers to care and (2) quality of life (QoL) for women with HIV. The ELLA (EpidemioLogical study to investigate the popuLation and disease characteristics, barriers to care, and quAlity of life for women living with HIV) study enrolled HIV-positive women aged ≥18 years. Women completed the 12-item Barriers to Care Scale (BACS) questionnaire. QoL was assessed using the Health Status Assessment. BACS and QoL were stratified by dichotomized HIV disclosure status (to anyone outside the healthcare system). Multilevel logistic regression analysis was used to identify factors associated with disclosure. Of 1945 patients enrolled from Latin America, China, central/eastern Europe, and western Europe/Canada between July 2012 and September 2013, 1929 were included in the analysis (disclosed, n = 1724; nondisclosed, n = 205). Overall, 55% of patients lived with a husband/partner, 53% were employed, and 88% were receiving antiretroviral therapy. Patients who were with a serodiscordant partner were more likely to disclose (p = 0.0003). China had a disproportionately higher percentage of participants who did not disclose at all (nearly 30% vs. <15% for other regions). Mean BACS severity scores for medical/psychological service barriers and most personal resource barriers were significantly lower for the disclosed group compared with the nondisclosed group (p ≤ 0.02 for all). Compared with the disclosed group, the nondisclosed group reported statistically significantly higher (p ≤ 0.03) BACS item severity scores for 8 of the 12 potential barriers to care. The disclosed group reported better QoL. Overall, HIV nondisclosure was associated with more severe barriers to accessing healthcare by women with HIV.

Abstract Full-text [free] access

Editor’s notes: This study drew women participants from Latin America, China, central and eastern Europe and from western Europe and Canada.  China was the only Asian country included and no African countries were included. This is important background information since the first sentence of the abstract ‘women are less likely than men to disclose HIV status’ is less likely to be true for, for example, parts of Africa. The study did not include men. So, no comparison can therefore be made with men’s disclosure behaviour. Nevertheless, the paper draws on data from 27 countries. Most women in the study did have access to ‘efficacious, well-tolerated’ antiretroviral therapy. A number of women, most notably in China, did not disclose their HIV status outside the health care system. Many women disclosed their status to a limited extent (only to some family and close friends). Non-disclosure affected access to health care as well as more general support. This pattern of non- or limited disclosure and barriers to access to care is replicated in many other places. The findings in this paper point to the importance globally of tackling stigma and providing a supportive health care and social setting for people living with HIV, so they can benefit fully from the treatment and care that is available.

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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.

Abstract access  

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. 

Northern America
United States of America
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Couples learning from couples: now is the time to test together

Evaluation of a demand-creation intervention for couples' HIV testing services among married or cohabiting individuals in Rakai, Uganda: a cluster-randomized intervention trial.

Matovu JK, Todd J, Wanyenze RK, Kairania R, Serwadda D, Wabwire-Mangen F. BMC Infect Dis. 2016 Aug 8;16:379. doi: 10.1186/s12879-016-1720-y.

Background: Uptake of couples' HIV counseling and testing (couples' HCT) services remains largely low in most settings. We report the effect of a demand-creation intervention trial on couples' HCT uptake among married or cohabiting individuals who had never received couples' HCT.

Methods: This was a cluster-randomized intervention trial implemented in three study regions with differing HIV prevalence levels (range: 9-43 %) in Rakai district, southwestern Uganda, between February and September 2014. We randomly assigned six clusters (1:1) to receive the intervention or serve as the comparison arm using computer-generated random numbers. In the intervention clusters, individuals attended small group, couple and male-focused interactive sessions, reinforced with testimonies from 'expert couples', and received invitation coupons to test together with their partners at designated health facilities. In the comparison clusters, participants attended general adult health education sessions but received no invitation coupons. The primary outcome was couples' HCT uptake, measured 12 months post-baseline. Baseline data were collected between November 2013 and February 2014 while follow-up data were collected between March and April 2015. We conducted intention-to-treat analysis using a mixed effects Poisson regression model to assess for differences in couples' HCT uptake between the intervention and comparison clusters. Data analysis was conducted using STATA statistical software, version 14.1.

Results: Of 2135 married or cohabiting individuals interviewed at baseline, 42% (n = 846) had ever received couples' HCT. Of those who had never received couples' HCT (n = 1174), 697 were interviewed in the intervention clusters while 477 were interviewed in the comparison clusters. 73.6% (n = 513) of those interviewed in the intervention and 82.6% (n = 394) of those interviewed in the comparison cluster were interviewed at follow-up. Of those interviewed, 72.3% (n = 371) in the intervention and 65.2% (n = 257) in the comparison clusters received HCT. Couples' HCT uptake was higher in the intervention than in the comparison clusters (20.3% versus 13.7%; adjusted prevalence ratio (aPR) = 1.43, 95% CI: 1.02, 2.01, P = 0.04).

Conclusion: Our findings show that a small group, couple and male-focused, demand-creation intervention reinforced with testimonies from 'expert couples', improved uptake of couples' HCT in this rural setting.

Trial registration: ClinicalTrials.gov, NCT02492061. Date of registration: June 14, 2015.

Abstract  Full-text [free] access

Editor’s notes: Effective programmes to increase HIV testing uptake are necessary, given new guidance from WHO recommending an immediate offer of antiretroviral therapy (ART) to all people who test HIV-positive regardless of CD4 count. This HIV testing demand creation trial involving married or cohabiting couples residing in Rakai, Uganda sheds light on strategies for achieving 90% knowledge of HIV-positive serostatus among all people living with HIV. In reality, HIV-serodiscordant couples have a striking 50% HIV prevalence from their partnership. Knowledge of serostatus is therefore critical to preventing HIV transmission to the HIV-negative partner and to an offspring. Such knowledge is also the doorway to early initiation of ART with its proven clinical benefits for the HIV-positive partner and reduced risk of HIV transmission to the HIV-negative partner. This intervention trial contributes to the literature on couples’ testing uptake generated through studies in Rwanda and Zambia in which influential network agents invited couples to take up HIV testing and counselling together. This trial was conducted in a highly studied population that has undergone annual sero-surveillance for over 20 years. At baseline 94.6% of individuals interviewed had already had an HIV test, 42% had a history of previous couples’ HIV testing and counselling (HTC), and 62.3% had had tested for HIV in the past year. People who had never received couples’ HTC formed the study populations. Couples in the programme clusters participated in couple- and male-focused demand creation small groups in which ‘expert couples’ shared their couple testing experiences. It is not possible to know which components of this relatively expensive programme were most effective. Uptake of couples HTC was modest at 20.3% compared with 13.7% in the control arm. Since this trial was conducted, new promising technologies have come on the horizon, including self-testing and point of care testing. Combining these with concerted efforts to reduce stigma and discrimination while increasing access to ART should see steady increases in uptake of couples’ HCT. Further, there is enough evidence now to suggest that engaging men and encouraging couple-to-couple conversations about testing can influence couples’ decisions to have an HIV test.

Africa
Uganda
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