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The feasibility of recruiting and retaining men who have sex with men and transgender women in a multinational prospective HIV prevention research cohort study in sub?Saharan Africa (HPTN 075)

ABSTRACT: Abstract Introduction Men who have sex with men (MSM) and transgender women (TGW) in sub?Saharan Africa (SSA) are profoundly affected by HIV with high HIV prevalence and incidence. This population also faces strong social stigma and legal barriers, potentially impeding participation in research. To date, few multi?country longitudinal HIV research studies with MSM/TGW have been conducted in SSA. Primary objective of the HIV Prevention Trials Network (HPTN) 075 study was to assess feasibility of recruiting and retaining a multinational prospective cohort of MSM/TGW in SSA for HIV prevention research. Methods HPTN 075, conducted from 2015 to 2017, was designed to enroll 400 MSM/TGW at four sites in SSA (100 per site: Kisumu, Kenya; Blantyre, Malawi; Cape Town, South Africa; and Soweto, South Africa). The number of HIV?positive persons was capped at 20 per site; HIV?positive persons already in care were excluded from participation. The one?year study included five biobehavioural assessments. Community?based input and risk mitigation protocols were included in study design and conduct. Results Of 624 persons screened, 401 were enrolled. One in five participants was classified as transgender. Main reasons for ineligibility included: (a) being HIV positive after the cap was reached (29.6%); (b) not reporting anal intercourse with a man in the preceding three months (20.6%); and (c) being HIV positive and already in care (17.5%). Five (1.2%) participants died during the study (unrelated to study participation). 92.9% of the eligible participants (368/396) completed the final study visit and 86.1% participated in all visits. The main, overlapping reasons for early termination included being (a) unable to adhere to the visit schedule, predominantly because of relocation (46.4%), and (b) unable to contact the participant (32.1%). Participants reported strong motivation to participate and few participation barriers. Four participants reported social harms (loss of confidentiality and sexual harassment by study staff) that were successfully addressed. Conclusions HPTN 075 successfully enrolled a multinational sample of MSM/TGW in SSA in a prospective HIV prevention research study with a high retention rate and few documented social harms. This supports the feasibility of conducting large?scale research trials in this population to address its urgent, unmet HIV prevention needs.

SUBMITTER: Sandfort T

PROVIDER: S-EPMC7527761 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Project description:Throughout the world, men who have sex with men (MSM) are at increased risk for HIV infection compared to heterosexual men. Little is known about awareness of HIV infection and other gaps in the HIV care continuum for MSM, especially in sub-Saharan Africa (SSA). This information is urgently needed to address the HIV epidemic in this population. This study assessed gaps in the HIV care continuum among persons screened for participation in a multi-country prospective study that evaluated the feasibility of recruiting and retaining MSM for HIV prevention studies in SSA (HIV Prevention Trials Network (HPTN) 075, conducted in four cities in Kenya, Malawi, and South Africa). Participants were recruited using site-specific strategies, that included outreach and informal networks. Transgender women (TW) were eligible to participate. During screening, 601 MSM and TW were tested for HIV infection and asked about prior HIV testing, HIV status, engagement in care, and HIV treatment. Viral load testing and retrospective antiretroviral (ARV) drug testing were performed for HIV-infected participants. Most participants (92.2%) had a prior HIV test; 42.1% were last tested >6 months earlier. HIV prevalence was 30.4%. HIV infection was associated with older age and identifying as female or transgender; 43.7% of the HIV-infected participants were newly diagnosed, especially younger persons and persons with a less recent HIV test. Almost a third of previously-diagnosed participants were not linked to care. Most participants (88.7%) in care were on ARV treatment (ART). Only about one-quarter of all HIV-infected participants were virally suppressed. These findings demonstrate substantial prevalence of undiagnosed HIV infection and sub-optimal HIV care engagement among MSM and TW in SSA. Increased HIV testing frequency and better linkage to care represent critical steps in preventing further HIV transmission in this population. Once in care, gaps in the HIV care continuum appear less critical.

Project description:BackgroundTransgender men (TGM) are underrepresented in genital microbiome research. Our prospective study in Birmingham, AL investigated genital microbiota changes over time in TGM initiating testosterone, including the development of incident bacterial vaginosis (iBV). Here, we present lessons learned from recruitment challenges encountered during the conduct of this study.MethodsInclusion criteria were assigned female sex at birth, TGM or non-binary identity, age ≥18 years, interested in injectable testosterone but willing to wait 7 days after enrollment before starting, and engaged with a testosterone-prescribing provider. Exclusion criteria were recent antibiotic use, HIV/STI infection, current vaginal infection, pregnancy, or past 6 months testosterone use. Recruitment initiatives included community advertisements via flyers, social media posts, and referrals from local gender health clinics.ResultsBetween February 2022 and October 2023, 61 individuals contacted the study, 17 (27.9%) completed an in-person screening visit, and 10 (58.8%) of those screened were enrolled. The primary reasons for individuals failing study screening were having limited access to testosterone-prescribing providers, already being on testosterone, being unwilling to wait 7 days to initiate testosterone therapy, or desiring the use of topical testosterone. Engagement of non-White TGM was also minimal.ConclusionDespite robust study inquiry by TGM, screening and enrollment challenges were faced including engagement by TGM not yet in care and specific study eligibility criteria. Excitement among TGM for research representation should be leveraged in future work by engaging transgender community stakeholders at the inception of study development, particularly regarding feasibility of study inclusion and exclusion criteria, as well as recruitment of TGM of color. These results also highlight the need for more clinical resources for prescribing gender-affirming hormone therapy, especially in the Southeastern US.

Project description:Sub-Saharan Africa represents 69% of the total number of individuals living with HIV infection worldwide and 72% of AIDS deaths globally. Pulmonary infection is a common and frequently fatal complication, though little is known regarding the lower airway microbiome composition of this population. Our objectives were to characterize the lower airway microbiome of Ugandan HIV-infected patients with pneumonia, to determine relationships with demographic, clinical, immunological, and microbiological variables and to compare the composition and predicted metagenome of these communities to a comparable cohort of patients in the US (San Francisco). Bronchoalveolar lavage samples from a cohort of 60 Ugandan HIV-infected patients with acute pneumonia were collected. Amplified 16S ribosomal RNA was profiled and aforementioned relationships examined. Ugandan airway microbiome composition and predicted metagenomic function were compared to US HIV-infected pneumonia patients. Among the most common bacterial pulmonary pathogens, Pseudomonas aeruginosa was most prevalent in the Ugandan cohort. Patients with a richer and more diverse airway microbiome exhibited lower bacterial burden, enrichment of members of the Lachnospiraceae and sulfur-reducing bacteria and reduced expression of TNF-alpha and matrix metalloproteinase-9. Compared to San Franciscan patients, Ugandan airway microbiome were significantly richer, and compositionally distinct with predicted metagenomes that encoded a multitude of distinct pathogenic pathways e.g secretion systems. Ugandan pneumonia-associated airway microbiome is compositionally and functionally distinct from those detected in comparable patients in developed countries, a feature which may contribute to adverse outcomes in this population. Please note that the data from the comparable cohort of patients in the USUS data was published as supplemental material of PMID: 22760045 but not submitted to GEO The 'patient_info.txt' contains 12 clinical, 7 immunological and 3 microbiological variables for each patient.

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The feasibility of recruiting and retaining men who have sex with men and transgender women in a multinational prospective HIV prevention research cohort study in sub?Saharan Africa (HPTN 075)

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