NCT02577380

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
Last Updated

August 15, 2017

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

October 1, 2015

Last Update Submit

August 11, 2017

Conditions

Intimate Partner Violence

Outcome Measures

Primary Outcomes (1)

  • Comparison of HTC experiences

    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

Study Arms (2)

IPV/GBV HIV testing and counseling

EXPERIMENTAL

For the randomized controlled trial, first-time antenatal care clients will be randomly assigned to IPV/GBV HTC HIV testing.

Behavioral: IPV/GBV HTC

Standard HIV testing and counseling

NO INTERVENTION

For the randomized controlled trial, first-time antenatal care clients will be randomly assigned to Standard HIV testing and counseling.

Interventions

IPV/GBV HTCBEHAVIORAL

Participants will be interviewed after receiving their services.

IPV/GBV HIV testing and counseling

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Haberland N, Ndwiga C, McCarthy K, Pulerwitz J, Kosgei R, Mak'anyengo M, Peltz A, Wong VJ, Kalibala S. Addressing Intimate Partner Violence and Power in Intimate Relationships in HIV Testing Services in Nairobi, Kenya. AIDS Behav. 2020 Aug;24(8):2409-2420. doi: 10.1007/s10461-020-02801-9.

    PMID: 32026250DERIVED

Study Officials

  • Nicole Haberland, MPH

    Population Council

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2015

First Posted

October 16, 2015

Study Start

June 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

August 15, 2017

Record last verified: 2017-08