Measurement of HIV Risk to Create Demand for Safe Male Circumcision

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.

Study Overview

• Status: Unknown
• Conditions: HIV
• Intervention / Treatment: Behavioral: Measurement and communication of HIV risk; Behavioral: Standard HIV testing and counseling

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 Type: Interventional
• Enrollment (Actual): 968
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Rakai
    • Kalisizo, Rakai, Uganda, 256
      • Rakai Health Sciences Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced HIV counseling and testing; 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.	Behavioral: Measurement and communication of HIV risk; Measurement and communication of HIV risk in the context of HIV testing and counseling to inform HIV risk reduction counseling
Active Comparator: Standard HIV testing and counseling; 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.	Behavioral: Standard HIV testing and counseling; Participants received HIV testing and counseling following standard Ministry of Health guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circumcision status as reported on a questionnaire and confirmed by examination	Circumcision status of men ascertained using a questionnaire and confirmed by examination	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Condom use at last non-marital relationship as reported on a questionnaire	Condom use at last non-marital sex ascertained using questionnaire self reports	6 months

Collaborators and Investigators

• Sponsor: Rakai Health Sciences Program
• Collaborators: Johns Hopkins Bloomberg School of Public Health; Bill and Melinda Gates Foundation; Makerere University
• Investigators: Principal Investigator: Joseph Kagaayi, Ph.D, Rakai Health Sciences Program

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: May 12, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Estimate): May 17, 2016
• Last Update Submitted That Met QC Criteria: May 12, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: OPP1118591

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be published in peer-reviewed journals and at scientific conferences.