HIVNCT02449733
Comprehensive HIV Prevention Package for MSM in Port Elizabeth
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 1 site in South Africa.
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
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteSouth Africa
- Study dates
- May 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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, Port Elizabeth
- 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
1 site in 1 country.
About this 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
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.
- Conditions
- HIV
- Being tested
- Condom choices, Condom-compatible lubricant choices, Couples HIV counseling and testing (CVCT), Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), HIV Testing
- 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.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)Drug
Also called Truvada
FTC/TDF is a once daily oral tablet taken with or without food. The tablet includes 200 mg of emtricitabine (FTC) and 300 mg of tenofovir disoproxil fumarate (TDF).
For men who meet eligibility criteria, Pre-exposure prophylaxis (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.
HIV TestingOther
Rapid HIV testing at multiple time points
Linkage to careOther
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 sexually transmitted infections (STIs )will be treated at the clinic site.
Post-exposure prophylaxis (PEP)Procedure or surgery
Two to three antiretroviral medicines as soon as possible (recommended is emtricitabine/tenofovir disoproxil fumarate plus either raltegravir or dolutegravir), but no more than 72 hours (3 days) after one may have been exposed to HIV, to try to reduce the chance of becoming HIV-positive. They must be taken for 28 days.
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.
| Study group | Role | What they receive |
|---|---|---|
| HIV+ subjects | Experimental | 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 Receives: Behavioral: Condom choices; Behavioral: Condom-compatible lubricant choices; Behavioral: Couples HIV counseling and testing (CVCT); Other: Linkage to care; Behavioral: Risk-reduction counseling |
| HIV- subjects | Experimental | 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. Receives: Behavioral: Condom choices; Behavioral: Condom-compatible lubricant choices; Behavioral: Couples HIV counseling and testing (CVCT); Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF); Other: HIV Testing; Other: Linkage to care; Procedure: Post-exposure prophylaxis (PEP); Behavioral: Risk-reduction counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in the cohort
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.
Measured: 12 months
Use of PrEP
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.
Measured: 6 months
Incident HIV infection
This will be measured as the number of seroconversions during follow-up among those who are HIV-uninfected at baseline.
Measured: 12 months
Secondary outcomes (6)
Condom use
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.
Measured: 3 months
Lubricant use
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.
Measured: 3 months
VCT and CVCT uptake
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.
Measured: 12 months
Serodiscordant unprotected anal intercourse (UAI)
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.
Measured: 3 months
Acceptability of PEP
Measured as the proportion of men who report an eligible exposure who accept and initiate PEP.
Measured: 12 months
MSM-specific provider training
Measured as the proportion of providers who are offered training who accept the training.
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 posted20 May 2015 (estimated)
- Study startMay 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.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 101 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, CCFP, Principal investigator, Johns Hopkins Bloomberg School of Public HealthNancy Phaswanamafuya, PhD, Principal investigator, Human Sciences Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449733
- Sponsor's protocol ID
- IRB00079727
- Status last verified
- Jul 2017
- First submitted
- 18 May 2015
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive HIV Prevention Package for MSM in Port Elizabeth
- ClinicalTrials.gov ID
- NCT02449733
- Acronym / sponsor ID
- IRB00079727
- 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
- 101 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 20 May 2015 (estimated)
- Results
- Not posted in the source record
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
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV+ subjects | Experimental | Behavioral: Condom choices, Behavioral: Condom-compatible lubricant choices, Behavioral: Couples HIV counseling and testing (CVCT), Other: Linkage to care, Behavioral: Risk-reduction counselingMen 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 | Experimental | Behavioral: Condom choices, Behavioral: Condom-compatible lubricant choices, Behavioral: Couples HIV counseling and testing (CVCT), Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Other: HIV Testing, Other: Linkage to care, Procedure: Post-exposure prophylaxis (PEP), Behavioral: Risk-reduction counselingMen 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. |
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, Port Elizabeth
- 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 | HIV+ subjects, HIV- subjects |
| 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 | HIV+ subjects, HIV- subjects |
| 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 | HIV+ subjects, HIV- subjects |
| Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)Also: TruvadaFTC/TDF is a once daily oral tablet taken with or without food. The tablet includes 200 mg of emtricitabine (FTC) and 300 mg of tenofovir disoproxil fumarate (TDF). For men who meet eligibility criteria, Pre-exposure prophylaxis (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. | Drug | HIV- subjects |
| HIV TestingRapid HIV testing at multiple time points | Other | HIV- subjects |
| 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 sexually transmitted infections (STIs )will be treated at the clinic site. | Other | HIV+ subjects, HIV- subjects |
| Post-exposure prophylaxis (PEP)Two to three antiretroviral medicines as soon as possible (recommended is emtricitabine/tenofovir disoproxil fumarate plus either raltegravir or dolutegravir), but no more than 72 hours (3 days) after one may have been exposed to HIV, to try to reduce the chance of becoming HIV-positive. They must be taken for 28 days. | Procedure or surgery | HIV- subjects |
| 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 | HIV+ subjects, HIV- subjects |
Primary outcome
Retention in the cohort
Time frame: 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
Time frame: 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
Time frame: 12 months
This will be measured as the number of seroconversions during follow-up among those who are HIV-uninfected at baseline.
6 secondary outcomes
Condom use
Time frame: 3 months
Lubricant use
Time frame: 3 months
VCT and CVCT uptake
Time frame: 12 months
Serodiscordant unprotected anal intercourse (UAI)
Time frame: 3 months
Acceptability of PEP
Time frame: 12 months
MSM-specific provider training
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
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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, CCFP principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: 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 1 site in South Africa.
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 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 6 Jul 2017.