HIVNCT02043015
Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study (Sibanye Health Project)
A study testing Condom choices, Condom-compatible lubricant choices and Couples HIV counseling and testing (CVCT) in people with HIV, run by Emory University at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Condom choices, Condom-compatible lubricant choices and Couples HIV counseling and testing (CVCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Feb 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 38Show fewer
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Rollins School of Public Health
Atlanta, Georgia, 30322
Johns Hopkins School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study
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.
Read the 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:
- Determine acceptability of the HIV prevention package.
- Determine uptake of individual elements of the HIV prevention package.
- Determine incidence of HIV, STIs and unprotected anal intercourse (UAI).
- Understand HIV risk and prevention behaviors among MSM.
Participating Sites:
- Emory University, Atlanta, Georgia
- Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
- University of California, Los Angeles, Los Angeles, California
- Desmond Tutu HIV Foundation, Cape Town, South Africa (Enrollment \& Clinic site)
- Conditions
- HIV
- Being tested
- Condom choices, Condom-compatible lubricant choices, Couples HIV counseling and testing (CVCT), Pre-exposure prophylaxis with FTC/TDF, Staff and provider MSM and LGBT sensitization training
- Keywords
- voluntary counseling and testing (VCT), couples voluntary counseling and testing (CVCT), pre-exposure prophylaxis (PrEP), homosexuality, male, South Africa
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Condom choicesBehavioural
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 choicesBehavioural
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)Behavioural
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.
Pre-exposure prophylaxis with FTC/TDFDrug
Also called PrEP
For men who meet eligibility criteria, 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. Men who accept PrEP will be required to have clinic visits, in addition to the regularly scheduled study visits, one month after starting PrEP and at least every 3 months afterward to monitor blood creatinine, AST/ALT and phosphorus levels.
Staff and provider MSM and LGBT sensitization trainingOther
The training for clinicians will focus on specific sexual health issues for MSM, including taking sexual histories in a non-judgmental way, physical examination techniques including anal examinations, and collection of rectal swabs for STI testing. Trainings will include topics about stigma, sexual identity and coming out, anal sex, STIs, and mental health. Training on LGBT sensitization will be provided for medical providers and staff in target clinics.
HIV Testing and Risk-reduction counselingBehavioural
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.
Linkage to careBehavioural
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 STIs will be treated at the clinic site.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive HIV prevention services | Other | 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 Receives: Behavioral: Condom choices; Behavioral: Condom-compatible lubricant choices; Behavioral: Couples HIV counseling and testing (CVCT); Drug: Pre-exposure prophylaxis with FTC/TDF; Other: Staff and provider MSM and LGBT sensitization training; Behavioral: HIV Testing and Risk-reduction counseling; Behavioral: Linkage to care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in the Cohort
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.
Measured: 12 months
Use of PrEP
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.
Measured: 4 months
Number of Participants With New HIV Infection
Incident HIV infection is measured as the number of seroconversions during follow-up among those who are HIV-uninfected at baseline.
Measured: 12 months
Secondary outcomes (7)
Condom Use
Condom use is measured as the number of male anal sex partners that the study participant always used condoms with in the prior three or six months, as self-reported reported in the questionnaire at each study visit.
Measured: Months 3, 6, and 12
Lubricant Use
Measured as the number and percentage of participants who used condom-compatible lubricant during their most recent anal sex act, among those who also used a condom at their most recent anal sex act.
Measured: Months 3, 6, and 12
Voluntary Counseling and Testing (VCT) and Couples Voluntary Counseling and Testing (CVCT) Uptake
VCT and CVCT is measured as the number and percentage of participants who completed VCT in the study period as part of the study visits and the number and percentage of participants who self-reported VCT outside of their study visits. These are compared to the number and percentage of participants who self-reported having VCT in the year prior at baseline. CVCT is measured as the number and percentage of participants who completed a CVCT session as part of the study.
Measured: 12 months
Number of HIV Tests During Study
The number of HIV tests per participant administered during the study period.
Measured: 12 months
Serodiscordant Unprotected Anal Intercourse (UAI)
Measured as any self-reported unprotected anal intercourse in the last three or six months with a partner of opposite or unknown HIV status, as self-reported in the questionnaire at each study visit.
Measured: Month 3, 6, and 12
Acceptability of Post-exposure Prophylaxis (PEP)
Measured as the number of men who report an eligible exposure who accept and initiate PEP.
Measured: 12 months
Acceptability of Provider Training
Measured as the number of providers who accept the training related to MSM-specific healthcare.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startFeb 2015
- Primary completionOct 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick S Sullivan, Emory University
- Investigators
- Patrick S Sulivan, DVM, PhD, Principal investigator, Rollins School of Public HealthA.D. McNaghten, PhD, MHSA, Principal investigator, Rollins School of Public HealthStefan Baral, MD, MPH, Principal investigator, Johns Hopkins Bloomberg School of Public HealthLinda-Gail Bekker, MBChB, PhD, Principal investigator, Desmond Tutu HIV FoundationRob Stephenson, MSc, PhD, Principal investigator, Rollins School of Public HealthChris Beyrer, MD, MPH, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043015
- Sponsor's protocol ID
- IRB00054863
- Other IDs
- MP3-1R01A1094575
- Status last verified
- Sep 2018
- First submitted
- 21 Jan 2014
- Last updated
- 17 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25325296
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study
- ClinicalTrials.gov ID
- NCT02043015
- Acronym / sponsor ID
- IRB00054863
- Conditions
- HIV
- Keywords
- voluntary counseling and testing (VCT), couples voluntary counseling and testing (CVCT), pre-exposure prophylaxis (PrEP), homosexuality, male, South Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Posted 17 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine acceptability of the HIV prevention package.
- Determine uptake of individual elements of the HIV prevention package.
- Determine incidence of HIV, STIs and unprotected anal intercourse (UAI).
- Understand HIV risk and prevention behaviors among MSM.
Participating Sites:
- Emory University, Atlanta, Georgia
- Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
- University of California, Los Angeles, Los Angeles, California
- Desmond Tutu HIV Foundation, Cape Town, South Africa (Enrollment \& Clinic site)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comprehensive HIV prevention services | Other | Behavioral: Condom choices, Behavioral: Condom-compatible lubricant choices, Behavioral: Couples HIV counseling and testing (CVCT), Drug: Pre-exposure prophylaxis with FTC/TDF, Other: Staff and provider MSM and LGBT sensitization training, Behavioral: HIV Testing and Risk-reduction counseling, Behavioral: Linkage to careA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Condom choicesMen 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. | Behavioural | Comprehensive HIV prevention services |
| Condom-compatible lubricant choicesMen 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. | Behavioural | Comprehensive HIV prevention services |
| 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. | Behavioural | Comprehensive HIV prevention services |
| Pre-exposure prophylaxis with FTC/TDFAlso: PrEPFor men who meet eligibility criteria, 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. Men who accept PrEP will be required to have clinic visits, in addition to the regularly scheduled study visits, one month after starting PrEP and at least every 3 months afterward to monitor blood creatinine, AST/ALT and phosphorus levels. | Drug | Comprehensive HIV prevention services |
| Staff and provider MSM and LGBT sensitization trainingThe training for clinicians will focus on specific sexual health issues for MSM, including taking sexual histories in a non-judgmental way, physical examination techniques including anal examinations, and collection of rectal swabs for STI testing. Trainings will include topics about stigma, sexual identity and coming out, anal sex, STIs, and mental health. Training on LGBT sensitization will be provided for medical providers and staff in target clinics. | Other | Comprehensive HIV prevention services |
| HIV Testing and Risk-reduction counselingRisk-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. | Behavioural | Comprehensive HIV prevention services |
| Linkage to careMen 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 STIs will be treated at the clinic site. | Behavioural | Comprehensive HIV prevention services |
Primary outcome
Retention in the Cohort
Time frame: 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
Time frame: 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.
Number of Participants With New HIV Infection
Time frame: 12 months
Incident HIV infection is measured as the number of seroconversions during follow-up among those who are HIV-uninfected at baseline.
7 secondary outcomes
Condom Use
Time frame: Months 3, 6, and 12
Lubricant Use
Time frame: Months 3, 6, and 12
Voluntary Counseling and Testing (VCT) and Couples Voluntary Counseling and Testing (CVCT) Uptake
Time frame: 12 months
Number of HIV Tests During Study
Time frame: 12 months
Serodiscordant Unprotected Anal Intercourse (UAI)
Time frame: Month 3, 6, and 12
Acceptability of Post-exposure Prophylaxis (PEP)
Time frame: 12 months
Acceptability of Provider Training
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25325296McNaghten 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick S Sulivan, DVM, PhD principal investigator
Rollins School of Public Health
A.D. McNaghten, PhD, MHSA principal investigator
Rollins School of Public Health
Stefan Baral, MD, MPH principal investigator
Johns Hopkins Bloomberg School of Public Health
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Condom choices, Condom-compatible lubricant choices and Couples HIV counseling and testing (CVCT) in people with HIV, run by Emory University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in the Cohort (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02043015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.