Clinical trial NCT02775357: Measurement of HIV Risk to Create Demand for Safe Male Circumcision
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Lead sponsor: Rakai Health Sciences Program
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Johns Hopkins Bloomberg School of Public Health
name: Makerere University
First posted: 2016-05-17
Enrollment: 968
Sex: MALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Uncircumcised, non-muslim, HIV-negative, sexually active in the previous 12 months

Exclusion Criteria:

* Refuses HIV testing, not willing to stay in Rakai for at least 6 months following enrollment or unwilling to be traced

Primary outcomes:
measure: Circumcision status as reported on a questionnaire and confirmed by examination
timeFrame: 6 months
Secondary outcomes:
measure: Condom use at last non-marital relationship as reported on a questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Kalisizo
country: Uganda
facility: Rakai Health Sciences Program
state: Rakai
Study officials:
affiliation: Rakai Health Sciences Program
name: Joseph Kagaayi, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: