HIVNCT02775357
Measurement of HIV Risk to Create Demand for Safe Male Circumcision
A study testing Measurement and communication of HIV risk and Standard HIV testing and counseling in people with HIV, run by Rakai Health Sciences Program at 1 site in Uganda.
Trial summary
The study is aimed at testing whether use of a new index to measure risk for HIV in the context of HIV testing and counseling will increase demand for safe male circumcision (SMC) services among HIV-negative non-muslim men in Rakai. Read more about this study
- Who is it for?
- Ages 15 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Measurement and communication of HIV risk and Standard HIV testing and counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 968 participants
- Where
- 1 siteUganda
- Study dates
- Nov 2014to Jun 2016
- 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 15 to 49 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Uncircumcised, non-muslim, HIV-negative, sexually active in the previous 12 months
Who cannot join
- Refuses HIV testing, not willing to stay in Rakai for at least 6 months following enrollment or unwilling to be traced
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using the Rakai HIV Risk Index to Measure and Communicate HIV Risk to Create Demand for Safe Male Circumcision: A Randomized Controlled Trial
The study is aimed at testing whether use of a new index to measure risk for HIV in the context of HIV testing and counseling will increase demand for safe male circumcision (SMC) services among HIV-negative non-muslim men in Rakai. We will also study whether use of the index leads to positive sexual behavioral modifications among men. The study will also measure acceptability of the index among men.
Read the detailed description
Three randomized trials, one of which was conducted in Rakai, Uganda, have shown that safe male circumcision (SMC) reduces HIV acquisition in men by approximately 60%. Recommendations from the World Health Organization (WHO) and the Joint United Nations Programme (UNAIDS) emphasize that SMC should be considered an efficacious intervention for HIV prevention in countries and regions with heterosexual epidemics, high HIV and low male circumcision prevalence.
In Sub Saharan Africa, 14 countries including Uganda have been selected to scale up SMC, for these countries the target is to achieve 80% circumcision prevalence by 2015 and maintain it till 2025. The scale up would avert more than 20 percent of new infections among men and women. However SMC programs are faced with the challenge of low uptake of SMC by older sexually active men who might be at higher risk of HIV. The need to increase SMC coverage among men at high risk of HIV requires tools to measure individual HIV risk.
Rakai Health Sciences Program has received funding to carry out an individual randomized, unblinded, two-arm 1:1 trial comprising a total of 968 men (484 men per study arm) from Rakai Community Cohort Study (RCCS) to assess whether HIV Counseling and Testing (HCT), enhanced with measurement and communication of HIV risk (eHCT), increases uptake of SMC and leads to behavior modification among HIV-negative sexually active men aged 15-49 years in Rakai District, Uganda.
The study is using a risk nomogram developed from the Rakai Community Cohort Study data to measure individual HIV risk in the intervention group and standard HCT in the control arm. All men enrolled will be followed at six months to ascertain circumcision status and collect brief information on sexual behaviors such as number of sex partners, use of alcohol with sex, detailed data on their sexual partners etc.The study will also measure acceptability of the index among men.
- Conditions
- HIV
- Being tested
- Measurement and communication of HIV risk, Standard HIV testing and counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement and communication of HIV riskBehavioural
Measurement and communication of HIV risk in the context of HIV testing and counseling to inform HIV risk reduction counseling
Standard HIV testing and counselingBehavioural
Participants received HIV testing and counseling following standard Ministry of Health guidelines
| Study group | Role | What they receive |
|---|---|---|
| Enhanced HIV counseling and testing | Experimental | In addition to standard HIV testing and counseling,men randomized to this arm received Measurement and communication of HIV risk from the HIV counselors using an index developed and validated through the Rakai community cohort study. Their risk was communicated to them and subsequent HIV risk reduction counseling including male circumcision was given. Receives: Behavioral: Measurement and communication of HIV risk |
| Standard HIV testing and counseling | Active comparator | Men randomized to this arm were given standard HIV testing and counseling following the current Uganda Ministry of Health guidelines. Following the counseling HIV risk reduction counseling including male circumcision was given. Receives: Behavioral: Standard HIV testing and counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circumcision status as reported on a questionnaire and confirmed by examination
Circumcision status of men ascertained using a questionnaire and confirmed by examination
Measured: 6 months
Secondary outcomes (1)
Condom use at last non-marital relationship as reported on a questionnaire
Condom use at last non-marital sex ascertained using questionnaire self reports
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startNov 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 968 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rakai Health Sciences Program
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Johns Hopkins Bloomberg School of Public Health, Makerere University
- Responsible party
- Sponsor
- Investigators
- Joseph Kagaayi, Ph.D, Principal investigator, Rakai Health Sciences Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775357
- Sponsor's protocol ID
- OPP1118591
- Status last verified
- Apr 2016
- First submitted
- 7 Apr 2016
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be published in peer-reviewed journals and at scientific conferences.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Rakai HIV Risk Index to Measure and Communicate HIV Risk to Create Demand for Safe Male Circumcision: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02775357
- Acronym / sponsor ID
- OPP1118591
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 968 participants (actual)
- Lead sponsor
- Rakai Health Sciences ProgramUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Johns Hopkins Bloomberg School of Public Health, Makerere University
- Study start
- Nov 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 17 May 2016 (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 study is aimed at testing whether use of a new index to measure risk for HIV in the context of HIV testing and counseling will increase demand for safe male circumcision (SMC) services among HIV-negative non-muslim men in Rakai. We will also study whether use of the index leads to positive sexual behavioral modifications among men. The study will also measure acceptability of the index among men.
Detailed description
Three randomized trials, one of which was conducted in Rakai, Uganda, have shown that safe male circumcision (SMC) reduces HIV acquisition in men by approximately 60%. Recommendations from the World Health Organization (WHO) and the Joint United Nations Programme (UNAIDS) emphasize that SMC should be considered an efficacious intervention for HIV prevention in countries and regions with heterosexual epidemics, high HIV and low male circumcision prevalence.
In Sub Saharan Africa, 14 countries including Uganda have been selected to scale up SMC, for these countries the target is to achieve 80% circumcision prevalence by 2015 and maintain it till 2025. The scale up would avert more than 20 percent of new infections among men and women. However SMC programs are faced with the challenge of low uptake of SMC by older sexually active men who might be at higher risk of HIV. The need to increase SMC coverage among men at high risk of HIV requires tools to measure individual HIV risk.
Rakai Health Sciences Program has received funding to carry out an individual randomized, unblinded, two-arm 1:1 trial comprising a total of 968 men (484 men per study arm) from Rakai Community Cohort Study (RCCS) to assess whether HIV Counseling and Testing (HCT), enhanced with measurement and communication of HIV risk (eHCT), increases uptake of SMC and leads to behavior modification among HIV-negative sexually active men aged 15-49 years in Rakai District, Uganda.
The study is using a risk nomogram developed from the Rakai Community Cohort Study data to measure individual HIV risk in the intervention group and standard HCT in the control arm. All men enrolled will be followed at six months to ascertain circumcision status and collect brief information on sexual behaviors such as number of sex partners, use of alcohol with sex, detailed data on their sexual partners etc.The study will also measure acceptability of the index among men.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced HIV counseling and testing | Experimental | Behavioral: Measurement and communication of HIV riskIn addition to standard HIV testing and counseling,men randomized to this arm received Measurement and communication of HIV risk from the HIV counselors using an index developed and validated through the Rakai community cohort study. Their risk was communicated to them and subsequent HIV risk reduction counseling including male circumcision was given. |
| Standard HIV testing and counseling | Active comparator | Behavioral: Standard HIV testing and counselingMen randomized to this arm were given standard HIV testing and counseling following the current Uganda Ministry of Health guidelines. Following the counseling HIV risk reduction counseling including male circumcision was given. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Uncircumcised, non-muslim, HIV-negative, sexually active in the previous 12 months
Key exclusion criteria (1 listed)
- Refuses HIV testing, not willing to stay in Rakai for at least 6 months following enrollment or unwilling to be traced
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 |
|---|---|---|
| Measurement and communication of HIV riskMeasurement and communication of HIV risk in the context of HIV testing and counseling to inform HIV risk reduction counseling | Behavioural | Enhanced HIV counseling and testing |
| Standard HIV testing and counselingParticipants received HIV testing and counseling following standard Ministry of Health guidelines | Behavioural | Standard HIV testing and counseling |
Primary outcome
Circumcision status as reported on a questionnaire and confirmed by examination
Time frame: 6 months
Circumcision status of men ascertained using a questionnaire and confirmed by examination
1 secondary outcome
Condom use at last non-marital relationship as reported on a questionnaire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Individual participant dataSharing planned: No. Data will be published in peer-reviewed journals and at scientific conferences.
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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.
Joseph Kagaayi, Ph.D principal investigator
Rakai Health Sciences Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement and communication of HIV risk and Standard HIV testing and counseling in people with HIV, run by Rakai Health Sciences Program at 1 site in Uganda.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 May 2016. 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 Uganda. 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?
Results are not available in the source record.
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?
Circumcision status as reported on a questionnaire and confirmed by examination (time frame: 6 months). 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 17 May 2016.