Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Number of Participants With New HIV Infection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Comprehensive HIV prevention services
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
干预措施: Condom choices (Behavioral)
Comprehensive HIV prevention services
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
干预措施: Condom-compatible lubricant choices (Behavioral)
Comprehensive HIV prevention services
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
干预措施: Couples HIV counseling and testing (CVCT) (Behavioral)
Comprehensive HIV prevention services
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
干预措施: Pre-exposure prophylaxis with FTC/TDF (Drug)
Comprehensive HIV prevention services
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
干预措施: Staff and provider MSM and LGBT sensitization training (Other)
Comprehensive HIV prevention services
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
干预措施: HIV Testing and Risk-reduction counseling (Behavioral)
Comprehensive HIV prevention services
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
干预措施: Linkage to care (Behavioral)
结局指标
主要结局
Number of Participants With New HIV Infection
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Lubricant Use(Months 3, 6, and 12)
- Voluntary Counseling and Testing (VCT) and Couples Voluntary Counseling and Testing (CVCT) Uptake(12 months)
- Number of HIV Tests During Study(12 months)
- Condom Use(Months 3, 6, and 12)
- Serodiscordant Unprotected Anal Intercourse (UAI)(Month 3, 6, and 12)
- Acceptability of Post-exposure Prophylaxis (PEP)(12 months)
- Acceptability of Provider Training(12 months)
研究者
Patrick S Sullivan
Principal Investigator
Emory University