Client-Centered Counseling During Routine/Opt-Out HIV-Testing in Uganda

May 7, 2015 updated by: Susan M. Kiene
This study pilot tests and intervention to help individuals reduce their risk for acquiring or transmitting HIV. The intervention is implemented when people are tested for HIV in an outpatient clinic in rural Uganda. Approximately half of participants will receive the intervention and the other half will receive the usual counseling provided during HIV counseling and testing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

333

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Gombe, Uganda
        • Gombe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. at least 18 years of age,
  2. have come to the outpatient clinic for a medical concern (e.g., cough, malaria, but not those seeking voluntary HIV-counseling and testing,
  3. sexually active within the prior 3-months,
  4. not currently pregnant,
  5. no confirmed HIV-positive test result prior to the present HIV-test, and
  6. live not more than 30km from Gombe Hospital in Uganda (to facilitate follow-up)

Exclusion Criteria:

  • less than 18 years of age,
  • having come to the clinic seeking voluntary HIV-counseling and testing,
  • not sexually active in prior 3 months,
  • currently pregnant,
  • confirmed prior HIV positive test,
  • live more than 30km from the hospital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motivational interviewing counseling

The brief intervention is adapted from the OPTIONS project, which is a brief client-centered risk reduction intervention for HIV-positive patients in clinical care. The OPTIONS intervention content is based upon the IMB model of health behavior change, and uses motivational interviewing techniques to create client-centered discussions in which HIV counselors and patients collaborate to identify patients' HIV transmission risk behaviors and to mutually identify strategies and goals for reducing the patient's risky behavior.

The brief intervention will be facilitated by health care providers (nurses, lab technicians) specifically trained in the intervention protocol and will consist of 2 brief counseling sessions occurring during the same-day rapid HIV-testing procedure
Behavioral: Motivational interviewing intervention during HIV testing
Active Comparator: Standard of care counseling
Participants in this study condition will receive standard-of-care counseling that is usually implemented during HIV testing.
Behavioral: Standard-of-care counseling during HIV testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual risk behavior
Time Frame: 6 months
Unprotected sex with serodiscordant or unknown HIV status partners
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of partner testing
Time Frame: 6 months
Partner uptake of HIV testing
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Susan M. Kiene

Collaborators

National Institute of Mental Health (NIMH)
Rhode Island Hospital
Makerere University

Investigators

  • Principal Investigator: Susan M Kiene, PhD, UConn Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

May 6, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Estimate)

May 8, 2015

Last Update Submitted That Met QC Criteria

May 7, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • SK_UG_K01
  • K01MH083536 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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