N/A
N=115
Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study (Sibanye Health Project)
HIV
Bottom Line
View on ClinicalTrials.gov: NCT02043015 ↗Enrolled (actual)
115
Serious AEs
2.0%
Results posted
Jan 2018
Primary outcome: Primary: Retention in the Cohort — 88; 84; 87 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Condom choices (Behavioral); Condom-compatible lubricant choices (Behavioral); Couples HIV counseling and testing (CVCT) (Behavioral); Pre-exposure prophylaxis with FTC/TDF (Drug); Staff and provider MSM and LGBT sensitization training (Other); HIV Testing and Risk-reduction counseling (Behavioral); Linkage to care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Emory University
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention in the Cohort |
88; 84; 87 | — |
| PRIMARY Use of PrEP |
39; 6 | — |
| PRIMARY Number of Participants With New HIV Infection |
6 | — |
| SECONDARY Condom Use |
84; 82; 84 | — |
| SECONDARY Lubricant Use |
17; 14; 9 | — |
| SECONDARY Voluntary Counseling and Testing (VCT) and Couples Voluntary Counseling and Testing (CVCT) Uptake |
57; 76; 53; 1 | — |
| SECONDARY Number of HIV Tests During Study |
4.9 | — |
| SECONDARY Serodiscordant Unprotected Anal Intercourse (UAI) |
11; 5; 4 | — |
| SECONDARY Acceptability of Post-exposure Prophylaxis (PEP) |
— | — |
| SECONDARY Acceptability of Provider Training |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02043015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.