Addressing Gender Based Violence in HIV Testing and Counseling

August 11, 2017 updated by: Population Council
The overarching goal of this study is to pilot an approach to HIV testing and counseling (HTC) that addresses intimate partner violence. The results of the study will fill an important gap in the literature and contribute to efforts by Kenyatta National Hospital in Nairobi, Kenya-and the HIV and sexual and reproductive health field globally-to better address intimate partner violence in our work.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

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

15 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Lived in the community for at least one year
  • Aged 15-49 years
  • Satisfy gender requirement

Exclusion Criteria:

  • Lack of informed consent

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IPV/GBV HIV testing and counseling
For the randomized controlled trial, first-time antenatal care clients will be randomly assigned to IPV/GBV HTC HIV testing.
Behavioral: IPV/GBV HTC
Participants will be interviewed after receiving their services.
No Intervention: Standard HIV testing and counseling
For the randomized controlled trial, first-time antenatal care clients will be randomly assigned to Standard HIV testing and counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of HTC experiences
Time Frame: 10 months
Number of ANC clients who meet an expected result of a survey with the intervention group (IPV/GBV-HTC) or with the control group (standard HTC). The score is based on answers given to attitudes toward study participant knowledge regarding IPV/GBV; awareness of IPV/GBV services; and agency regarding talking with their partner about HIV testing.
10 months

Collaborators and Investigators

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

Sponsor

Population Council

Collaborators

United States Agency for International Development (USAID)

Investigators

  • Principal Investigator: Nicole Haberland, MPH, Population Council

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

June 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

October 1, 2015

First Submitted That Met QC Criteria

October 13, 2015

First Posted (Estimate)

October 16, 2015

Study Record Updates

Last Update Posted (Actual)

August 15, 2017

Last Update Submitted That Met QC Criteria

August 11, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Population Council # 640

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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