Comprehensive HIV Prevention Package for MSM in Port Elizabeth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Retention in the cohort
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
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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, Port Elizabeth
- •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
HIV+ subjects
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
干预措施: Condom choices (Behavioral)
HIV+ subjects
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
干预措施: Condom-compatible lubricant choices (Behavioral)
HIV+ subjects
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
干预措施: Couples HIV counseling and testing (CVCT) (Behavioral)
HIV+ subjects
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
干预措施: Linkage to care (Other)
HIV+ subjects
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
干预措施: Risk-reduction counseling (Behavioral)
HIV- subjects
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.
干预措施: Condom choices (Behavioral)
HIV- subjects
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.
干预措施: Condom-compatible lubricant choices (Behavioral)
HIV- subjects
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.
干预措施: Couples HIV counseling and testing (CVCT) (Behavioral)
HIV- subjects
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.
干预措施: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) (Drug)
HIV- subjects
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.
干预措施: HIV Testing (Other)
HIV- subjects
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.
干预措施: Linkage to care (Other)
HIV- subjects
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.
干预措施: Post-exposure prophylaxis (PEP) (Procedure)
HIV- subjects
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.
干预措施: Risk-reduction counseling (Behavioral)
结局指标
主要结局
Retention in the cohort
时间窗: 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
时间窗: 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
时间窗: 12 months
This will be measured as the number of seroconversions during follow-up among those who are HIV-uninfected at baseline.
次要结局
- Condom use(3 months)
- Lubricant use(3 months)
- VCT and CVCT uptake(12 months)
- Serodiscordant unprotected anal intercourse (UAI)(3 months)
- Acceptability of PEP(12 months)
- MSM-specific provider training(12 months)
研究者
Patrick S Sullivan
Principal Investigator
Emory University