Comprehensive HIV Prevention Package for MSM in Port Elizabeth

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Condom choices; Behavioral: Condom-compatible lubricant choices; Behavioral: Couples HIV counseling and testing (CVCT); Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF); Behavioral: Risk-reduction counseling; Other: HIV Testing; Other: Linkage to care; Procedure: Post-exposure prophylaxis (PEP)

• Registration Number: NCT02449733
• 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

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-20
• Primary Completion: 2016-10
• Study Completion: 2017-03
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-04
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 101

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HIV- subjects	Condom choices	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.
HIV- subjects	Linkage to care	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.
HIV+ subjects	Condom choices	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
HIV- subjects	Condom-compatible lubricant choices	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.
HIV+ subjects	Couples HIV counseling and testing (CVCT)	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
HIV- subjects	Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)	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.
HIV+ subjects	Condom-compatible lubricant choices	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
HIV+ subjects	Linkage to care	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
HIV+ subjects	Risk-reduction counseling	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
HIV- subjects	HIV Testing	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.
HIV- subjects	Couples HIV counseling and testing (CVCT)	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.
HIV- subjects	Risk-reduction counseling	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.
HIV- subjects	Post-exposure prophylaxis (PEP)	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.

Primary Outcome Measures

Name	Time	Method
Retention in the cohort	12 months	Will assess the ability of the study to retain participants for full study period. This will be measured by the proportion of enrolled participants who attend all subsequent study visits through the 12-month visit.
Use of PrEP	6 months	Will assess uptake of PrEP by study participants. This will be measured as the proportion of enrolled participants eligible for PrEP at the 3 and 6-month study visits who choose to initiate PrEP at those visits.
Incident HIV infection	12 months	This will be measured as the number of seroconversions during follow-up among those who are HIV-uninfected at baseline.

Secondary Outcome Measures

Name	Time	Method
Condom use	3 months	Measured as the proportion of anal intercourse that is protected by condoms in the prior 3 months as self-reported reported in the questionnaire at each study visit.
Lubricant use	3 months	Measured as the proportion of condom-protected anal intercourse in the prior for 3 months for which condom-compatible lubricant is used as self-reported in the questionnaire at each study visit.
VCT and CVCT uptake	12 months	Measured as the number of times participants report HIV testing in the study period as part of the study visits and outside study visits compared to the number of time participants reported HIV testing in the year prior at baseline.
Serodiscordant unprotected anal intercourse (UAI)	3 months	Measured as self-reported UAI in the last 3 months with a partner of positive or unknown HIV status as self-reported in the questionnaire at each study visit, pre- and post-intervention.
Acceptability of PEP	12 months	Measured as the proportion of men who report an eligible exposure who accept and initiate PEP.
MSM-specific provider training	12 months	Measured as the proportion of providers who are offered training who accept the training.

Trial Locations

Locations (1)

Human Sciences Research Council; 🇿🇦 Port Elizabeth, South Africa