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Study Overview

Title:
Increasing HIV Testing among Male Partners of Ante-Natal clinic (ANC) Clients: a Randomized Study in Kenya
Study ID:
RIDIE-STUDY-ID-5a746a40a5ad1
Initial Registration Date:
02/02/2018
Last Update Date:
01/15/2018
Study Status:
Completed
Location(s):
Kenya
Abstract:
Background: In Kenya, antenatal care (ANC) attendance and HIV testing at first ANC is nearly universal. Despite a policy promoting male partner testing in ANC, very few male partners accompany their partners at ANC for HIV testing. We evaluated the impact of using oral HIV self-testing on HIV testing among male partners of ANC clients in Kenya. Methods: In a three-arm randomized controlled study in 14 ANC sites in Eastern and Central Kenya, consenting women were randomized to receiving, in one of three study arms: 1) standard-of-care; 2) a card stating the importance of male HIV testing; 3) or two OraQuick® HIV oral self-test kits. Women completed a baseline questionnaire and an endline questionnaire after three months. Consenting male partners were surveyed three months after enrolling female ANC clients. The primary outcome was male partner HIV testing as reported by their female partner. Results: All women who attended first ANC in the participating facilities were approached and screened for eligibility, 1,410 women were randomized, of which 1,215 were successfully followed up while 1,133 men consented to the survey. 79.4% (335/422) of the women in the self-testing gro
Categories:
Health, Nutrition, and Population
Additional Keywords:
HIV, oral HIV self-testing, male involvement, Partner testing
Secondary ID Number(s):
2014-PRP-180

Principal Investigator(s)

Name of First PI:
Anthony Gichangi
Affiliation:
Jhpiego
Name of Second PI:
Prof Jeff Korte
Affiliation:
Medical University of South Carolina

Study Sponsor

Name:
International initiative for impact evaluation (3ie)
Study Sponsor Location:
United States
Funding Proposal:
01_Jhpiego_3ie Kenya_Technical Proposal.docx

Research Partner

Name of Partner Institution:
Medical University of South Carolina
Type of Organization:
Research institute/University
Website:
Location:
United States
Intervention

Intervention Overview

Intervention:
Randomization: Eligible participants were individually randomized into one of the three study groups using opaque envelopes after informed consent. Intervention delivery: The study nurse then provided the relevant information and items based on the study group designation. Group 1: The study nurse gave the participant the standard Kenyan MOH brochure, inviting the male partner to come to the clinic for a discussion on the health of their family, but did not specifically mention HIV. Group 2: The study nurse gave the client an improved invitation letter developed by the study team, describing the benefits to the family and the man’s own health when both partners know their HIV status, as well as information on the possibility of sero-discordance. Group 3 (intervention group: oral HIV self-test kit and improved letter): The study nurse gave the client the same improved invitation letter as in group 2, plus two OraQuick® HIV oral self-test kits and instructional material on how to use the oral self-test kit with user-friendly pictorial instruction. Follow-up: Three months after enrolment, participants were followed up to ascertain whether the male partner tested for HIV.
Private Intervention Details:
Theory of Change:
Nested within several behavior change theories, including the AIDS Risk Reduction Model (ARRM) and the theory of planned behavior, the proposed intervention considered the importance of couple dynamics, social norms and environmental factors on utilisation of HIV testing services among male partners of pregnant women. Therefore, by providing oral self-test kits to the women at ANC, and assuming that women have self-efficacy to bring the kits home, the ANC clients brings the kit to the male partner. Assuming that women have confident and ability to present the kits to the partner, due to increased privacy, increased convenience, decreased transportation cost and increased self-efficacy there is increased motivation to test. Finally assuming that male partners have necessary self-efficacy to test there is increased HIV testing among men and increased knowledge of HIV status.
Multiple Treatment Arms Evaluated?
Yes

Implementing Agency

Name of Organization:
Jhpiego
Type of Organization:
NGO (International)

Program Funder

Name of Organization:
international initiative for impact evaluation
Type of Organization:
NGO (International)

Intervention Timing

Intervention or Program Started at time of Registration?
Yes
Start Date:
11/01/2014
End Date:
12/31/2016
Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:
Randomized control trial
Other (not Listed) Method:
Additional Evaluation Method (If Any):
Other (not Listed) Method:

Method Details

Details of Evaluation Approach:
Study Design: This was a three-arm, individually randomized controlled study. The three study arms were: 1) standard-of-care ('control group 1'); 2) a card stating the importance of male HIV testing ('control group 2'); 3) or two OraQuick® HIV oral self-test kits with test-kit information ('intervention group'). Evaluation:
Private Details of Evaluation Approach:
Outcomes (Endpoints):
The primary outcome of the study was HIV testing status by any method (clinic-based testing, oral self-testing, community health worker, etc.) of the male partner, as reported by the female partners. Any male partner HIV testing is the PMTCT goal.
Measurement:
Unit of Analysis:
individual male partners
Hypotheses:
Provision of Oral HIV Self-test Kits Triples Uptake of HIV Testing among Male Partners of Antenatal Care Clients. • Group 1 vs Group 2: We assume a baseline HIV testing for male partners of 6% and we hypothesized that was is difference between group 1 and group 2. Group 2 vs Group 3: We assumed that group 3 would have an uptake of male partner HIV testing of 20%, while group 2 would reach at least 11% (the upper limit of equivalence), based on a well-known conservativeness in male partner testing in ANC settings in Kenya
Unit of Intervention or Assignment:
individual ANC clients partners
Number of Clusters in Sample:
14 Health facilities
Number of Individuals in Sample:
1425 womer and 1425 men
Size of Treatment, Control, or Comparison Subsamples:
Study group 1 (475), Study group 2 (475), Study group 3 (475)

Supplementary Files

Analysis Plan:
Analysis Plan.docx
Other Documents:
Research Plan: 3ie Kenya Research Plan JHSPH IRB_Resubmission 4_6_2015 clean.pdf
Data

Outcomes Data

Description:
Women and their male partners were followed-up three months after enrollment and were interviewed using a structured questionnaire. Information as to whether the man tested for HIV after enrollment wasbe asked during the interview. Reported (by either the woman oor the man) HIV testing for the male partner was used as the primary outcome.
Data Already Collected?
Yes
Survey Name:
Increasing Male Partner testing using oral HIV self-test kits
Data Previously Used?
Yes
Data Access:
Restricted -- Access requires a formal approval process
Data Obtained by the Study Researchers?
Data Approval Process:
Write to research team of Jhpiego kenya (researchkenya@@jhpiego.org) with detailed description of the intended use and analysis plan.
Approval Status:
Yes-obtained approval and have received the data

Treatment Assignment Data

Participation or Assignment Information:
Yes
Description:
Data Obtained by the Study Researchers?
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Data Analysis

Data Analysis Status:
Yes

Study Materials

Upload Study Materials:

Registration Category

Registration Category:
Non-Prospective, Category 4: Data for measuring impacts have been obtained/collected by the research team and analysis for this evaluation has started
Completion

Completion Overview

Intervention Completion Date:
Data Collection Completion Date:
Unit of Analysis:
Clusters in Final Sample:
Total Observations in Final Sample:
Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:
Preliminary Report URL:
Summary of Findings:
Paper:
Paper Summary:
Paper Citation:

Data Availability

Data Availability (Primary Data):
Date of Data Availability:
Data URL or Contact:
Access procedure:

Other Materials

Survey:
Survey Instrument Links or Contact:
Program Files:
Program Files Links or Contact:
External Link:
External Link Description:
Description of Changes:

Study Stopped

Date:
Reason: