Clinical trial NCT02043015: Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study (Sibanye Health Project)
Official title: Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: voluntary counseling and testing (VCT)
couples voluntary counseling and testing (CVCT)
pre-exposure prophylaxis (PrEP)
homosexuality
male
South Africa
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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)

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

Primary outcomes:
measure: Retention in the Cohort
timeFrame: 12 months
measure: Use of PrEP
timeFrame: 4 months
measure: Number of Participants With New HIV Infection
timeFrame: 12 months
Secondary outcomes:
measure: Condom Use
timeFrame: Months 3, 6, and 12
measure: Lubricant Use
timeFrame: Months 3, 6, and 12
measure: Voluntary Counseling and Testing (VCT) and Couples Voluntary Counseling and Testing (CVCT) Uptake
timeFrame: 12 months
measure: Number of HIV Tests During Study
timeFrame: 12 months
measure: Serodiscordant Unprotected Anal Intercourse (UAI)
timeFrame: Month 3, 6, and 12
measure: Acceptability of Post-exposure Prophylaxis (PEP)
timeFrame: 12 months
measure: Acceptability of Provider Training
timeFrame: 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Rollins School of Public Health
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins School of Public Health
state: Maryland
city: Cape Town
country: South Africa
facility: Desmond Tutu HIV Foundation
Study officials:
affiliation: Rollins School of Public Health
name: Patrick S Sulivan, DVM, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rollins School of Public Health
name: A.D. McNaghten, PhD, MHSA
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Stefan Baral, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Desmond Tutu HIV Foundation
name: Linda-Gail Bekker, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rollins School of Public Health
name: Rob Stephenson, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Chris Beyrer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: McNaghten A, Kearns R, Siegler AJ, Phaswana-Mafuya N, Bekker LG, Stephenson R, Baral SD, Brookmeyer R, Yah CS, Lambert AJ, Brown B, Rosenberg E, Blalock Tharp M, de Voux A, Beyrer C, Sullivan PS. Sibanye Methods for Prevention Packages Program Project Protocol: Pilot Study of HIV Prevention Interventions for Men Who Have Sex With Men in South Africa. JMIR Res Protoc. 2014 Oct 16;3(4):e55. doi: 10.2196/resprot.3737.