Dataset Information

A Randomized Controlled Trial of the Shikamana Intervention to Promote Antiretroviral Therapy Adherence Among Gay, Bisexual, and Other Men Who Have Sex with Men in Kenya: Feasibility, Acceptability, Safety and Initial Effect Size.

ABSTRACT: Gay, bisexual, and other men who have sex with men (GBMSM) living with HIV in rights-constrained settings need support for antiretroviral therapy (ART) adherence due to barriers including stigma. The Shikamana intervention combined modified Next Step Counseling by providers with support from trained peers to improve adherence among GBMSM living with HIV in Kenya. A randomized controlled trial with 6-month follow-up was used to determine feasibility, acceptability, safety, and initial intervention effects. Generalized estimating equations examined differences in self-reported adherence and virologic suppression. Sixty men enrolled, with 27 randomly assigned to the intervention and 33 to standard care. Retention did not differ by arm, and no adverse events occurred. Feedback on feasibility and acceptability was positive based on exit interviews. After adjustment for baseline viral suppression and confounding, the intervention group had a sixfold increased odds of viral suppression during follow-up. A larger trial of a scaled-up intervention is needed.

SUBMITTER: Graham SM

PROVIDER: S-EPMC7319885 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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A Randomized Controlled Trial of the Shikamana Intervention to Promote Antiretroviral Therapy Adherence Among Gay, Bisexual, and Other Men Who Have Sex with Men in Kenya: Feasibility, Acceptability, Safety and Initial Effect Size.

Graham Susan M SM Micheni Murugi M Chirro Oscar O Nzioka Joseph J Secor Andrew M AM Mugo Peter M PM Kombo Bernadette B van der Elst Elise M EM Operario Don D Amico K Rivet KR Sanders Eduard J EJ Simoni Jane M JM

AIDS and behavior 20200701 7

Gay, bisexual, and other men who have sex with men (GBMSM) living with HIV in rights-constrained settings need support for antiretroviral therapy (ART) adherence due to barriers including stigma. The Shikamana intervention combined modified Next Step Counseling by providers with support from trained peers to improve adherence among GBMSM living with HIV in Kenya. A randomized controlled trial with 6-month follow-up was used to determine feasibility, acceptability, safety, and initial interventio ...[more]

PMID: 31965432

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Project description:BackgroundPreexposure prophylaxis is efficacious at preventing HIV infection, but concerns persist about adherence and sexually transmitted infections (STIs). We assessed preexposure prophylaxis acceptability, adherence and clinical outcomes in a pilot demonstration project.MethodsHIV-uninfected adult gay and bisexual men who scored 10 or higher on a validated HIV risk score (HIV Incidence Risk Index for MSM) and reported condomless receptive anal sex were sequentially enrolled into a 1-year open-label single-arm pilot study of daily oral therapy with tenofovir disoproxil fumarate/emtricitabine in Toronto. The primary outcome was acceptability of preexposure prophylaxis. Secondary outcomes were preexposure prophylaxis adherence (4-d recall, pill count and dried blood spot analysis), HIV seroconversion, STIs and adverse events.ResultsOf the 86 men screened, 52 were enrolled. Participants were mostly young (median age 33 yr [interquartile range (IQR) 28-37 yr) white (38 [73%]) gay (49 [94%]) men. Preexposure prophylaxis acceptability was high: all participants reported their experience as "good" or "very good." The median adherence rate was high, at 100% (IQR 95%-100%) by self-report and 96.9% (IQR 93.4%-98.4%) by pill count. Dried blood spot analysis suggested that doses were taken 4-7 days/week at 88.7% (173/195) of month 3-12 visits. No cases of HIV seroconversion occurred, but 25 participants (48%) experienced at least 1 bacterial STI, with incidence rates per 100 person-years of 32.8, 32.8, 8.2 and 8.2 for chlamydia, gonorrhea, syphilis and lymphogranuloma venereum, respectively. No adverse events led to discontinuation of prophylaxis, but the estimated glomerular filtration rate declined by 0.22 mL/min per month.InterpretationPreexposure prophylaxis was associated with high adherence and acceptability and no HIV infections in this study. Frequent STIs and clinically unapparent toxic renal effects reinforce the need for ongoing vigilance.Trial registrationClinicalTrials. gov, no. NCT02149888.

Project description:BackgroundGay, bisexual, and other cisgender men who have sex with men (GBMSM) are disproportionately affected by the HIV pandemic. Traditionally, GBMSM have been deemed less relevant in HIV epidemics in low- and middle-income settings where HIV epidemics are more generalized. This is due (in part) to how important population size estimates regarding the number of individuals who identify as GBMSM are to informing the development and monitoring of HIV prevention, treatment, and care programs and coverage. However, pervasive stigma and criminalization of same-sex practices and relationships provide a challenging environment for population enumeration, and these factors have been associated with implausibly low or absent size estimates of GBMSM, thereby limiting knowledge about the dynamics of HIV transmission and the implementation of programs addressing GBMSM.ObjectiveThis study leverages estimates of the number of members of a social app geared towards gay men (Hornet) and members of Facebook using self-reported relationship interests in men, men and women, and those with at least one reported same-sex interest. Results were categorized by country of residence to validate official size estimates of GBMSM in 13 countries across five continents.MethodsData were collected through the Hornet Gay Social Network and by using an a priori determined framework to estimate the numbers of Facebook members with interests associated with GBMSM in South Africa, Ghana, Nigeria, Senegal, Côte d'Ivoire, Mauritania, The Gambia, Lebanon, Thailand, Malaysia, Brazil, Ukraine, and the United States. These estimates were compared with the most recent Joint United Nations Programme on HIV/AIDS (UNAIDS) and national estimates across 143 countries.ResultsThe estimates that leveraged social media apps for the number of GBMSM across countries are consistently far higher than official UNAIDS estimates. Using Facebook, it is also feasible to assess the numbers of GBMSM aged 13-17 years, which demonstrate similar proportions to those of older men. There is greater consistency in Facebook estimates of GBMSM compared to UNAIDS-reported estimates across countries.ConclusionsThe ability to use social media for epidemiologic and HIV prevention, treatment, and care needs continues to improve. Here, a method leveraging different categories of same-sex interests on Facebook, combined with a specific gay-oriented app (Hornet), demonstrated significantly higher estimates than those officially reported. While there are biases in this approach, these data reinforce the need for multiple methods to be used to count the number of GBMSM (especially in more stigmatizing settings) to better inform mathematical models and the scale of HIV program coverage. Moreover, these estimates can inform programs for those aged 13-17 years; a group for which HIV incidence is the highest and HIV prevention program coverage, including the availability of pre-exposure prophylaxis (PrEP), is lowest. Taken together, these results highlight the potential for social media to provide comparable estimates of the number of GBMSM across a large range of countries, including some with no reported estimates.

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Project description:Gay, bisexual, and other men who have sex with men (GBMSM) are highly stigmatized and male-male sex is often criminalized in sub-Saharan Africa, impeding access to quality care for sexual health, HIV prevention, and treatment. To better understand HIV care engagement and antiretroviral therapy (ART) adherence among GBMSM in this context, a conceptual model incorporating sociocultural factors is needed. We conducted a qualitative study of barriers to and facilitators of HIV care engagement and ART adherence among Kenyan GBMSM, informed by a conceptual model based on an access, information, motivation, and behavioral skills (access-IMB) model, with trust in providers and stigma and discrimination as a priori factors of interest. We conducted 30 semi-structured interviews with HIV-positive Kenyan GBMSM, of whom 20 were taking ART and 10 had not yet initiated treatment. A deductive approach was used to confirm the relevance of basic concepts of the access-IMB model, while an inductive approach was used to identify content that emerged from men's lived experiences. Access-related information, motivation, and behavioral skills appeared relevant to HIV care engagement and ART adherence, with stigma and discrimination appearing consistently across discourse exploring facilitators and barriers. Trusted providers and supportive family and friends helped many men, and resilience-related concepts such as selective disclosure of GBMSM status, connection to lesbian, gay, bisexual, and transgender (LGBT) organizations, self-acceptance, goal-setting, social identity and altruism emerged as important facilitators. Findings suggest a need to increase support from providers and peers for Kenyan GBMSM living with HIV infection. In addition, they point toward the potential value of interventions that provide opportunities to build or enhance one's sense of community belonging in order to improve HIV care engagement and promote ART adherence for this vulnerable population.

Project description:BackgroundThe purpose of this study was to evaluate the relationship between cognitive performance, risk factors for cardiovascular and cerebrovascular disease (CVD), and HIV infection in the era of highly active antiretroviral therapy.MethodsWe evaluated the cognitive functions of men enrolled in the cardiovascular disease substudy of the Multicenter AIDS Cohort Study who were aged > or =40 years, with no self-reported history of heart disease or cerebrovascular disease. Results from comprehensive neuropsychological evaluations were used to construct composite scores of psychomotor speed and memory performance. Subclinical CVD was assessed by measuring coronary artery calcium and carotid artery intima-media thickness (IMT), as well as laboratory measures, including total cholesterol, fasting glucose, glycosylated hemoglobin, glomerular filtration rate (estimated), and standardized blood pressure and heart rate measures.ResultsAfter accounting for education, depression, and race, carotid IMT and glomerular filtration rate were significantly associated with psychomotor speed, whereas IMT was associated with memory test performance. HIV serostatus was not significantly associated with poorer cognitive test performance. However, among the HIV-infected individuals, the presence of detectable HIV RNA in plasma was linked to lower memory performance.ConclusionsThese findings suggest that HIV infection may not be the most important predictor of cognitive performance among older gay and bisexual men in the post-highly active antiretroviral therapy era, at least among those with access to medical care and to appropriate medications. Medical factors associated with normal aging are significantly associated with performance on neuropsychological tests, and good clinical management of these factors both in HIV-infected individuals and those at risk for infection may have beneficial effects in the short term and could reduce the risk of subsequent cognitive decline.

Dataset Information

A Randomized Controlled Trial of the Shikamana Intervention to Promote Antiretroviral Therapy Adherence Among Gay, Bisexual, and Other Men Who Have Sex with Men in Kenya: Feasibility, Acceptability, Safety and Initial Effect Size.

Publications

A Randomized Controlled Trial of the Shikamana Intervention to Promote Antiretroviral Therapy Adherence Among Gay, Bisexual, and Other Men Who Have Sex with Men in Kenya: Feasibility, Acceptability, Safety and Initial Effect Size.

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