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.
|
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
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.
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.