Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study (Sibanye Health Project)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the acceptability and uptake of a combination package of biomedical, behavioral and community-level HIV prevention interventions and services for men who have sex with men (MSM) in South Africa.

Detailed Description
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Study Design: This pilot study is a longitudinal cohort study of approximately 100 MSM, with a prospective follow-up period of 1 year for each participant. MSM will be recruited through community events, venues where MSM are known to congregate, online, and by participant referral. Following consent, a baseline visit will include a self-administered baseline survey, a clinical exam including an assessment for circumcision and STIs, and testing for HIV and other sexually transmitted infections (STIs), creatinine, AST/ALT and phosphorus levels, and drug screening. An HIV prevention package will be offered to participants starting at baseline, which will include condom choices, condom-compatible lubricant choices, risk-reduction counseling, linkage to care, and couples voluntary counseling and testing (CVCT). HIV-negative men can be screened for eligibility for pre-exposure prophylaxis (PrEP) with Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), which will be made available for eligible men beginning at the 1-month or 4-month study visit. Throughout the study, PEP for men with an exposure at high risk for HIV transmission will be made available. Men who test positive for HIV at baseline or during the study will be referred and actively linked to appropriate care and treatment services and will continue to be a part of the study. Men who test positive for STIs at baseline or during the study will receive treatment at the study clinic. Participants will complete follow-up visits at 3, 6, and 12 months that will include self-administered behavioral surveys and HIV testing, and STI testing at 6 and 12 months. Men who are eligible and interested in initiating PrEP can return for a PrEP initiation visit, which will include rapid HIV testing, at two time points: 1 month after enrollment and 4 months after enrollment. Men who initiate PrEP will have additional clinic visits for creatinine, AST/ALT, phosphate, protein and glucose level testing and rapid HIV testing the month following PrEP initiation (month 2 for those initiating PrEP at 1 month and month 5 for those initiating PrEP at 4 months) and every 3 months thereafter. If a participant on PrEP tests positive for HIV, they will discontinue PrEP but continue to be followed for their remaining study visits. Men who test positive for HIV at follow-up visits will have blood drawn for initial cluster of differentiation 4 (CD4) and HIV viral load testing, and will have CD4 testing at 6 and 12 months and HIV viral load testing at 3, 6, and 12 months. Data on service utilization, condom use, lubricant use, HIV and STI testing outside the study site, and other outcomes will be collected via monthly short message service (SMS) text message surveys during the study period. Study Population: The study population will be men aged 18 years and older who self-report that they had anal intercourse with men in the past year, are current residents of the study city, are willing to provide contact information, and have a phone. Study Size: The sample will consist of approximately 100 MSM in Cape Town, South Africa. All 100 men will be followed for one year, and approximately 20% of the study population can be HIV-infected at baseline. Additional men who are HIV-positive at baseline will be enrolled in the baseline visit but not followed prospectively, and not counted as part of the 100 men in that study site. Study Intervention: The prevention package will be offered throughout the study and will include condom choices with an assortment of styles, sizes and features, condom-compatible lubricant choices with discreet packaging, risk reduction counseling, linkage to care, couples voluntary HIV counseling and testing (CVCT), and PrEP for eligible men beginning one month after enrollment. Condom choices, lubricant choices, and CVCT will be available to participants at drop-in visits at any time. Throughout the study, post-exposure prophylaxis (PEP) for men with an exposure at high risk for HIV transmission will be available as standard of care. Community-level interventions will occur through training of health care providers to deliver sexual health services to MSM and lesbian, gay, bisexual, and transgender (LGBT) sensitization, LGBT training for study staff and other staff of the clinical sites, and community mobilization efforts to improve health literacy and uptake of prevention services among MSM. Study Duration: Recruitment activities will be conducted for 3 months or until 100 MSM have been recruited. After enrollment, MSM will have a follow-up period of 1 year for each participant. Primary Objectives: This study has four primary objectives: Determine acceptability of the HIV prevention package. Determine uptake of individual elements of the HIV prevention package. Determine incidence of HIV, STIs and unprotected anal intercourse (UAI). Understand HIV risk and prevention behaviors among MSM. Participating Sites: Emory University, Atlanta, Georgia Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland University of California, Los Angeles, Los Angeles, California Desmond Tutu HIV Foundation, Cape Town, South Africa (Enrollment & Clinic site)

Official Title
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Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Condom choices
* Behavioral: Condom-compatible lubricant choices
* Behavioral: Couples HIV counseling and testing (CVCT)
* Drug: Pre-exposure prophylaxis with FTC/TDF
* Other: Staff and provider MSM and LGBT sensitization training
* Behavioral: HIV Testing and Risk-reduction counseling
* Behavioral: Linkage to care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male sex at birth Anal sex with another man in the past 12 months 18 years of age or older Resident of the study city Able to complete study instruments, with or without assistance, in English, Xhosa or Afrikaans Willing to provide contact information Has a phone Exclusion Criteria: Not male sex at birth No self-reported anal sex with a man in the past 12 months Less than 18 years of age Not a resident of the study city Plans to move from the study city within the year after enrollment Not able to complete study instructions, with or without assistance, in English, Xhosa or Afrikaans Not willing to provide contact information Does not have a phone Additional Inclusion and Exclusion Criteria for participants on PrEP: PrEP Inclusion Criteria: Identified as high-risk for HIV by the provider by meeting one or more of the criteria below: Have multiple partners Engage in transactional sex, including sex workers Use or abuse drugs Drink alcohol heavily Had more than 1 episode of a STI in the last year Is the HIV-negative partner in a discordant relationship, especially if the HIV-positive partner is not on antiretroviral therapy (ART) Is in a non-monogamous concordant relationship with a HIV-negative partner Is unable or unwilling to achieve consistent use of male condoms No contra-indications to Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Calculated creatinine clearance of at least 60 mL/min Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2 x upper limit of normal (ULN) Hepatitis B surface antigen (HBsAg) negative Motivated to follow PrEP prescribing guidelines Willing to adhere to daily oral dosing Willing to attend PrEP maintenance visits every 3 months PrEP Exclusion Criteria: HIV positive Signs or symptoms suggestive of acute HIV infection Have baseline creatinine clearance <60 ml/min Are unwilling to follow PrEP prescribing guidelines Are unwilling to attend PrEP maintenance visits every 3 months Are known to have hypertensives or diabetes Are hepatitis B susceptible (test HBsAg and HBsAb negative) and refuse to take a hepatitis B vaccine series Any contraindication to taking FTC/TDF Proteinuria 2+ or greater at screening Glucosuria 2+ or greater at screening Use of antiretroviral (ARV) therapy (e.g., for PEP or PrEP) in the 90 days prior to study entry

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Comprehensive HIV prevention services<br>A comprehensive package of HIV prevention services, including condom choices, Condom-compatible lubricant choices, Couples HIV counseling and testing (CVCT), Staff and provider MSM and LGBT sensitization training, HIV Testing and Risk-reduction counseling, Linkage to care, Pre-exposure prophylaxis with FTC/TDF | Behavioral: Condom choices<br>* Men will receive the condom package that includes an assortment of styles, sizes, features and colors at their baseline visit, and will be able to get more condoms for free at any time after that visit by coming to a study clinic during clinic hours, or during a scheduled study visit.<br>Behavioral: Condom-compatible lubricant choices<br>* Men will receive condom-compatible lubricant that will include different types of lubricant (e.g., silicone-based) and different packaging (individual sachets or flat, discreet packages) at their baseline study visit, and participants will be able to access enhanced condom-compatible lubricant at any time after that visit by coming to a study clinic during clinic hours, or during a scheduled study visit.<br>Behavioral: Couples HIV counseling and testing (CVCT)<br>* Participants will be invited to schedule couples voluntary HIV counseling and testing (CVCT) appointments with a clinic counselor at any point after they complete their baseline study visit.<br>Drug: Pre-exposure prophylaxis with FTC/TDF<br>* For men who meet eligibility criteria, PrEP with Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) will be made available beginning one month into the study. Men who express interest and meet eligibility criteria at their baseline visit can initiate PrEP at 1 month if they test negative for HIV. For men with extenuating circumstances, whose risk profile changes, of those who become more comfortable with the PrEP intervention through enrollment in the study, PrEP will be available to initiate at the 4 month visit. Men who accept PrEP will be required to have clinic visits, in addition to the regularly scheduled study visits, one month after starting PrEP and at least every 3 months afterward to monitor blood creatinine, AST/ALT and phosphorus levels.<br>* Other names: PrEP;Other: Staff and provider MSM and LGBT sensitization training<br>* The training for clinicians will focus on specific sexual health issues for MSM, including taking sexual histories in a non-judgmental way, physical examination techniques including anal examinations, and collection of rectal swabs for STI testing. Trainings will include topics about stigma, sexual identity and coming out, anal sex, STIs, and mental health. Training on LGBT sensitization will be provided for medical providers and staff in target clinics.<br>Behavioral: HIV Testing and Risk-reduction counseling<br>* Risk-reduction counseling will be provided to all men at baseline and additionally at 3, 6, and 12 month visits, with an additional counseling session for men on PrEP at their initiation visit (either month 1 or 4), their 1-month follow-up visit (either month 2 or 5) and at their 9 month visit. Risk reduction counseling will be client-centered counseling, according to CDC's Fundamentals of HIV Prevention Counseling protocol.<br>Behavioral: Linkage to care<br>* Men will be linked to needed services including HIV care and treatment for positives identified at baseline or during the study, including antiretroviral medications, and mental health services. At the end of their baseline visit, participants will receive service referral handouts for HIV care and treatment, mental health services, and other resources, as appropriate. Men who test positive for STIs will be treated at the clinic site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention in the Cohort | The ability of the study to retain participants for full study period was assessed. Retention was measured by the number and percentage of enrolled participants attending study visits through the 12-month study period. | 12 months | 
| Use of PrEP | Uptake of PrEP by study participants was measured as the number and percentage of enrolled participants eligible for PrEP at the baseline and 3-month study visits who choose to initiate PrEP at a visit one month later. | 4 months | 
| Number of Participants With New HIV Infection | Incident HIV infection is measured as the number of seroconversions during follow-up among those who are HIV-uninfected at baseline. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Condom Use | Condom use is measured as the number of male anal sex partners that the study participant always used condoms with in the prior three or six months, as self-reported reported in the questionnaire at each study visit. | Months 3, 6, and 12 | 
| Lubricant Use | Measured as the number and percentage of participants who used condom-compatible lubricant during their most recent anal sex act, among those who also used a condom at their most recent anal sex act. | Months 3, 6, and 12 | 
| Voluntary Counseling and Testing (VCT) and Couples Voluntary Counseling and Testing (CVCT) Uptake | VCT and CVCT is measured as the number and percentage of participants who completed VCT in the study period as part of the study visits and the number and percentage of participants who self-reported VCT outside of their study visits. These are compared to the number and percentage of participants who self-reported having VCT in the year prior at baseline. CVCT is measured as the number and percentage of participants who completed a CVCT session as part of the study. | 12 months | 
| Number of HIV Tests During Study | The number of HIV tests per participant administered during the study period. | 12 months | 
| Serodiscordant Unprotected Anal Intercourse (UAI) | Measured as any self-reported unprotected anal intercourse in the last three or six months with a partner of opposite or unknown HIV status, as self-reported in the questionnaire at each study visit. | Month 3, 6, and 12 | 
| Acceptability of Post-exposure Prophylaxis (PEP) | Measured as the number of men who report an eligible exposure who accept and initiate PEP. | 12 months | 
| Acceptability of Provider Training | Measured as the number of providers who accept the training related to MSM-specific healthcare. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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voluntary counseling and testing (VCT), couples voluntary counseling and testing (CVCT), pre-exposure prophylaxis (PrEP), homosexuality, male, South Africa