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General

Study Overview

Title:

HIV self-testing for partners of women attending antenatal care in Central Uganda: Uptake and linkage to care post-test

Change History for Title

Changed On	Previous Value
08/22/2019	HIV self-testing for partners of women attending antenatal care in Central Uganda: Uptake and linkage to care post-test (grant agreement No. TW2.2.28))

Study is 3ie funded:

Yes

Study ID:

RIDIE-STUDY-ID-5d5e5415031cc

Initial Registration Date:

08/22/2019

Last Update Date:

08/22/2019

Study Status:

Completed

Location(s):

Uganda

Abstract:

 We implemented a phased cluster randomized controlled trial among pregnant women attending ANC in Mpigi Health Centre Level 4 (HCIV), Entebbe and Nakaseke Hospitals to 1) determine the uptake of HIV testing in the male partner; and 2) assess the linkage to care among HIV positive partners across the two study arms. We randomized clinic days to intervention or control. Women in the control arm were given health education and encouraged to bring their partners to test at the facility. Women in the intervention arm were additionally given HIVST kits to deliver to their partners. We conducted structured interviews with women at baseline, month one and month three post-enrolment and with the men at one month and three months post women’s enrolment. We also conducted a long term follow up sub study on HIV positive men and discordant couples at six and up to 24 months post enrolment. The primary outcomes were self-reported HIV testing, linkage to care post-test as defined by self-reported registration at an HIV clinic, and strategies for coping with discordant status reported by either the woman or male partner across Month 1 and 3 follow-ups; and up to 24

Categories:

Health, Nutrition, and Population

Additional Keywords:

HIV, HIV self-testing, partner testing, antenatal care, PMTCT, Uganda

Secondary ID Number(s):

TW2.2.28

Principal Investigator(s)

Name of First PI:

Rhoda Wanyenze

Affiliation:

Makerere University

Name of Second PI:

Jeffrey Korte

Affiliation:

Medical University of South Carolina

Study Sponsor

Name:

International Initiative for Impact Evaluation (3ie)

Study Sponsor Location:

United States

Research Partner

Name of Partner Institution:

Medical University of South Carolina

Type of Organization:

Research institute/University

Location:

United States

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.

Private Intervention Details:

Theory of Change:

The theory of change that guided this study was based on several key assumptions. First, we assumed that the counseling and training provided to the women in the intervention arm would increase their motivation and self-efficacy to take the self-testing kits home and present them to their husbands. We assumed that having a self-testing kit would mitigate against common barriers to HIV testing among men, including lost work time, transportation costs, and stigma. We assumed that self-testing would reduce these barriers by increasing the man’s sense of privacy, convenience, and low cost associated with HIV testing, leading to an increased likelihood of HIV testing. Furthermore, we assumed that having an HIV kit would increase the man’s sense of self-efficacy, control, and ownership of the process of HIV testing, increasing the likelihood that he will test. Our theory of the health impact of testing rested on the assumption that men testing positive were able to link to care and that medication was available.

In previous research with pregnant women delivering kits to their male partners (Gichangi et al. 2017), we found that rates of couple testing were very high, and consequently rates of disclosure were very high. Thus, previous research supports the hypothesis that home-based self-testing may result in high rates of disclosure as well as linkage to care.

Based on our theory of change, we formulated hypotheses that the impact of the intervention might vary by age, marital status, education, and religious affiliation, because these factors could be related to the woman’s self-efficacy and motivation to bring the kit home and present it to the man, as well as the man’s likelihood to respond positively and test for HIV. In addition, we planned to test for differential effects by study site because these and other factors may differ across sites.

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?

Yes

Start Date:

07/01/2016

End Date:

10/15/2018

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:

Our primary analysis for estimating the impact of the intervention was to perform a comparison of the primary outcome (male partner testing) in the intervention group versus the control group. In addition to unadjusted analyses comparing these two groups, we fit log-linear models with and without accounting for clustering by clinic day, and testing for covariate imbalance at baseline. We accounted for clustering using a random effect for clinic day, because this was the unit of group-level randomization across clinics. In addition, we included study site as a fixed effect, and tested study site (as well as other pre-determined hypothesized effect modifiers) for multiplicative interactions with intervention assignment.

We used log-binomial models to allow estimation of the relative risk, which we judged the most appropriate measure of association in this longitudinal study with interval-based assessment of a high-prevalence outcome measure (HIV testing).

Private Details of Evaluation Approach:

The final analysis consisted of participants with sufficient follow-up data which needed them to have  completed at least one of the two follow-up interviews. To be included in the final analysis, participants. In random-effects log-binomial models accounting for clustering by clinic day, we estimated the risk ratio for HIV testing among male partners, comparing the two study arms. The primary outcome measure was the woman’s self-report about whether her male partner had tested for HIV since the beginning of the study. Overall, we also conducted analyses accounting for both the report of the women and men, by considering a man to have tested if either he or the woman reported that he had done so.

Outcomes (Endpoints):

Our primary outcomes were the woman’s report whether her primary partner tested for HIV within the three-month follow-up period after the first ANC visit; and linkage to care among HIV positive partners.

Secondary outcomes included the number of HIV infections identified in the two study arms, negative social outcomes, costing analysis of HIV self-testing and coping skills for discordant couples who self-tested for HIV.

Unit of Analysis:

Main unit of analysis is the individual patient

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:

Our cluster was a clinic day across the three sites; 59 clusters from Nakaseke, in 108 clusters from Mpigi, and in 180 clusters from Entebbe.

Number of Individuals in Sample:

816 were recruited in the intervention arm and 742 in the control arm

Size of Treatment, Control, or Comparison Subsamples:

816 were recruited in the intervention arm and 742 in the control arm

Supplementary Files

Analysis Plan:

Other Documents:

Data

Outcomes Data

Description:

The dataset is a merged health facility based dataset in STATA. It comprise data collected from 3 different sites at 3 phases of the study; main study, phase 2 and phase 3. The participants are assigned to either intervention or control arm

Data Already Collected?

Yes

Data Previously Used?

Yes

Data Access:

Change History for Data Access

Changed On	Previous Value
08/22/2019	Restricted -- Access requires a formal approval process

Data Obtained by the Study Researchers?

Data Approval Process:

Change History for Data Approval Process

Changed On	Previous Value
08/22/2019	Write an email requesting for use of data to ; The Dean, Makerere University School of Public Health. P.O. Box 7072 Makerere Uganda

Approval Status:

Change History for Approval Status

Changed On	Previous Value
08/22/2019	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:

Change History for Data Analysis Status

Changed On	Previous Value
08/22/2019	Yes

Study Materials

Upload Study Materials:

survey instruments: Survey instruments.doc

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: