Measurement of HIV Risk to Create Demand for Safe Male Circumcision

NCT02775357 | Unknown

• 1 other identifier: OPP1118591
• Study Type: interventional
• Target: 968
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Condom use at last non-marital relationship as reported on a questionnaire

  6 months

Study Arms (2)

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.

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.

Behavioral: Standard HIV testing and counseling

Interventions

Measurement and communication of HIV risk BEHAVIORAL

Measurement and communication of HIV risk in the context of HIV testing and counseling to inform HIV risk reduction counseling

Enhanced HIV counseling and testing

Standard HIV testing and counseling BEHAVIORAL

Participants received HIV testing and counseling following standard Ministry of Health guidelines

Standard HIV testing and counseling

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rakai Health Sciences Program: lead
• Bill and Melinda Gates Foundation: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator
• Makerere University: collaborator

Study Sites (1)

Rakai Health Sciences Program

Kalisizo, Rakai, 256, Uganda

Location

MeSH Terms

Interventions

Weights and Measures; Counseling

Intervention Hierarchy (Ancestors)

Investigative Techniques; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Joseph Kagaayi, Ph.D

  Rakai Health Sciences Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: May 17, 2016
• Study Start: November 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 17, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)