Overview

This trial is active, not recruiting.

Condition hiv
Treatments condom choices, condom-compatible lubricant choices, couples hiv counseling and testing (cvct), emtricitabine/tenofovir disoproxil fumarate (ftc/tdf), hiv testing, linkage to care, post-exposure prophylaxis (pep), risk-reduction counseling
Sponsor Emory University
Start date May 2015
End date October 2016
Trial size 101 participants
Trial identifier NCT02449733, IRB00079727

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model crossover assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Men who test positive for HIV will receive a comprehensive package of HIV prevention services, including condom choices, condom-compatible lubricant choices, risk-reduction counseling, couples HIV counseling and testing, and linkage to care
condom choices
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.
condom-compatible lubricant choices
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.
couples hiv counseling and testing (cvct)
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.
linkage to care
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 sexually transmitted infections (STIs )will be treated at the clinic site.
risk-reduction counseling
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.
(Experimental)
Men who test negative for HIV will receive a comprehensive package of HIV prevention services, including condom choices, condom-compatible lubricant choices, enhanced HIV testing options, risk-reduction counseling, couples HIV counseling and testing, linkage to care, and screening for and offering of pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP). If men test positive for HIV during the study, they will be transitioned into the HIV+ subjects arm.
condom choices
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.
condom-compatible lubricant choices
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.
couples hiv counseling and testing (cvct)
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.
emtricitabine/tenofovir disoproxil fumarate (ftc/tdf) Truvada
FTC/TDF is a once daily oral tablet taken with or without food. The tablet includes 200 mg of emtricitabine (FTC) and 300 mg of tenofovir disoproxil fumarate (TDF). For men who meet eligibility criteria, Pre-exposure prophylaxis (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.
hiv testing
Rapid HIV testing at multiple time points
linkage to care
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 sexually transmitted infections (STIs )will be treated at the clinic site.
post-exposure prophylaxis (pep)
Two to three antiretroviral medicines as soon as possible (recommended is emtricitabine/tenofovir disoproxil fumarate plus either raltegravir or dolutegravir), but no more than 72 hours (3 days) after one may have been exposed to HIV, to try to reduce the chance of becoming HIV-positive. They must be taken for 28 days.
risk-reduction counseling
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.

Primary Outcomes

Measure
Retention in the cohort
time frame: 12 months
Use of PrEP
time frame: 6 months
Incident HIV infection
time frame: 12 months

Secondary Outcomes

Measure
Condom use
time frame: 3 months
Lubricant use
time frame: 3 months
VCT and CVCT uptake
time frame: 12 months
Serodiscordant unprotected anal intercourse (UAI)
time frame: 3 months
Acceptability of PEP
time frame: 12 months
MSM-specific provider training
time frame: 12 months

Eligibility Criteria

Male participants at least 18 years old.

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, Port Elizabeth - 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

Additional Information

Official title Comprehensive HIV Prevention Package for MSM in Port Elizabeth
Principal investigator Patrick S Sulivan, DVM, PhD
Description The objective of the Sibanye Health Project is to develop and evaluate a combination package of biomedical, behavioral and community-level HIV prevention interventions and services for men who have sex with men (MSM) in Africa. Experience implementing the prevention interventions and preliminary data collected regarding the acceptability of the HIV prevention package will be used to develop a proposal to design a larger efficacy trial to test the combination HIV prevention package for MSM.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Emory University.