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Study Overview

Title:
HIV self-testing for partners of women attending antenatal care in Central Uganda: Uptake and linkage to care post-test
Study is 3ie funded:
No
Study ID:
RIDIE-STUDY-ID-56e1817442fbf
Initial Registration Date:
03/10/2016
Last Update Date:
03/08/2016
Study Status:
In Development
Location(s):
Uganda
Abstract:
Couple HIV testing, HIV status disclosure and partner testing following individual testing are critical interventions to family HIV service access and improvement of outcomes for prevention of mother-to-child HIV transmission (PMTCT). Barriers to couple HIV testing, HIV status disclosure and partner testing during antenatal care (ANC) are due to a variety of supply (service delivery) and demand (largely social) factors. Key demand barriers include competing priorities such as work, stigma, long waiting time at health facilities, among others. Further, women may have challenges with negotiation with partners to encourage partner HIV testing. To overcome some of these barriers, our study is trying to integrate giving out HIV self-testing kits to partners through the pregnant women at ANC at three public facilities in Central Uganda to enable couple and partner self-testing. The overall aim of the study is to determine the effect of HIV self-testing (HIVST) on uptake and outcomes of partner HIV testing.
Categories:
Health, Nutrition, and Population
Additional Keywords:
HIV, HIV self-testing, partner testing, antenatal care, PMTCT, Uganda
Secondary ID Number(s):

Principal Investigator(s)

Name of First PI:
Rhoda Wanyenze
Affiliation:
Makerere University School of Public Health
Name of Second PI:
Affiliation:

Study Sponsor

Name:
International Initiative for Impact Evaluation (3ie)
Study Sponsor Location:
United States

Research Partner

Name of Partner Institution:
Type of Organization:
Location:
Intervention

Intervention Overview

Intervention:
The overall aim of the study is to determine the effect of HIV self-testing (HIVST) on uptake and outcomes of partner HIV testing, in a two-arm cluster randomized controlled trial that will evaluate the impact of providing HIV self-testing on the proportion of male partners being tested for HIV. The first arm is the control group arm, in which women will receive the standard of care including education for women to encourage their partners to test at the health facility. The second arm is the treatment arm, which will include standard of care plus the intervention of HIV self-testing kits. The primary objectives include: 1) To determine the uptake of HIV testing and the number of new HIV infections identified in the two study arms; and 2) To assess the linkage care among HIV positive partners across the two study arms. Structured interviews will be conducted with 1500 women at baseline, 1-, and 3-months, and with their partners at 1-, and 3-months after enrollment of the women. Further, key informant interviews will be conducted with providers and in-depth interviews with selected family members of the enrolled women.
Theory of Change:
Multiple Treatment Arms Evaluated?
Yes

Implementing Agency

Name of Organization:
Makerere University School of Public Health
Type of Organization:
Research Institution/University

Program Funder

Name of Organization:
International Initiative for Impact Evaluation (3ie)
Type of Organization:
NGO (International)

Intervention Timing

Intervention or Program Started at time of Registration?
No
Start Date:
07/01/2016
End Date:
05/31/2017
Evaluation Method

Evaluation Method Overview

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

Method Details

Details of Evaluation Approach:
To avoid contamination between the two study arms, we will randomize by clinic day in each clinic. This will occur using a pre-determined randomization scheme which will not be shared with non-study personnel to minimize bias. To determine the randomization assignment for each clinic day an electronic data entry system will be preprogrammed with randomization assignments. Women recruited from a clinic on a particular day will be in the same study arm, and will constitute a cluster in the cluster-randomized study design. The primary analysis will be conducted using the intention to treat analysis: clients’ data will be analyzed based on the randomized study arms, as opposed to the intervention they received. The primary outcome will be whether the woman self-reports that her primary partner tested for HIV within the three-month follow-up period after the first ANC visit. The initial comparison between groups will be a two-sided chi-square test of the association and the effect of the intervention will be quantified using the difference in proportion. To account for clustering, the main analysis will be conducted using generalized estimating equations (GEE).
Outcomes (Endpoints):
The primary outcome will be whether the woman self-reports that her primary partner tested for HIV within the three-month follow-up period after the first ANC visit. The time to HIV test will be another important secondary outcome that will be considered in the evaluation, which will be measured as time from randomization to the time the partner was reported testing for HIV. We will model the probability of having the male partner receiving a HIV test during the three months of follow-up, controlling for socio-demographic information and other characteristics.
Unit of Analysis:
Main unit of analysis is the individual patient. Primary outcome is whether her male partner tested for HIV. The main comparison between the intervention and control arms will account for clustering.
Hypotheses:
We hypothesize that the intervention group, Group 2 (HIVST), will have higher male partner testing rates than the comparison group (Group 1).
Unit of Intervention or Assignment:
The unit of intervention will be on the individual level.
Number of Clusters in Sample:
100 clusters of clinic days, spread across 3 clinics. We will have 50 clusters in each arm.
Number of Individuals in Sample:
We expect to recruit 1,500 women. We will attempt to recruit all male partners as well, for a maximum of 3,000 total participants.
Size of Treatment, Control, or Comparison Subsamples:
750 individuals in the treatment arm, and 750 individuals in the control arm.

Supplementary Files

Analysis Plan:
Other Documents:
Data

Outcomes Data

Description:
The primary outcome is the woman’s self report of whether her male partner tested for HIV. In parallel, we will also survey male partners who consent to join the study. The follow-up questionnaire for the ANC client and male partners will be delivered by telephone or in person, at 1 month and 3 month follow-ups. We will measure testing behaviors, attitudes and communication for her male partner and other adult family members. Relevant clinic visit cost parameters will be collected at 1 month
Data Already Collected?
No
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

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:

Study Materials

Upload Study Materials:

Registration Category

Registration Category:
Prospective, Category 1: Data for measuring impacts have not been collected
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: