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

Not Applicable

Completed

Conditions: HIV

Interventions: 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

Registration Number: NCT02043015

Lead Sponsor: Emory University

Brief Summary: 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: 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:

1. Determine acceptability of the HIV prevention package.

2. Determine uptake of individual elements of the HIV prevention package.

3. Determine incidence of HIV, STIs and unprotected anal intercourse (UAI).

4. Understand HIV risk and prevention behaviors among MSM.

Participating Sites:

1. Emory University, Atlanta, Georgia

2. Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland

3. University of California, Los Angeles, Los Angeles, California

4. Desmond Tutu HIV Foundation, Cape Town, South Africa (Enrollment \& Clinic site)

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 100

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Comprehensive HIV prevention services	Condom choices	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
Comprehensive HIV prevention services	Condom-compatible lubricant choices	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
Comprehensive HIV prevention services	Couples HIV counseling and testing (CVCT)	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
Comprehensive HIV prevention services	Pre-exposure prophylaxis with FTC/TDF	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
Comprehensive HIV prevention services	Staff and provider MSM and LGBT sensitization training	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
Comprehensive HIV prevention services	HIV Testing and Risk-reduction counseling	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
Comprehensive HIV prevention services	Linkage to care	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With New HIV Infection	12 months	Incident HIV infection is measured as the number of seroconversions during follow-up among those who are HIV-uninfected at baseline.
Retention in the Cohort	12 months	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.
Use of PrEP	4 months	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.

Secondary Outcome Measures

Name	Time	Method
Lubricant Use	Months 3, 6, and 12	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.
Condom Use	Months 3, 6, and 12	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.
Voluntary Counseling and Testing (VCT) and Couples Voluntary Counseling and Testing (CVCT) Uptake	12 months	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.
Number of HIV Tests During Study	12 months	The number of HIV tests per participant administered during the study period.
Serodiscordant Unprotected Anal Intercourse (UAI)	Month 3, 6, and 12	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.
Acceptability of Post-exposure Prophylaxis (PEP)	12 months	Measured as the number of men who report an eligible exposure who accept and initiate PEP.
Acceptability of Provider Training	12 months	Measured as the number of providers who accept the training related to MSM-specific healthcare.

Trial Locations

Locations (3): Johns Hopkins School of Public Health
🇺🇸
Baltimore, Maryland, United States
Rollins School of Public Health
🇺🇸
Atlanta, Georgia, United States
Desmond Tutu HIV Foundation
🇿🇦
Cape Town, South Africa

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

Recruitment & Eligibility

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