Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: HIV self-testing with partner notification.

• Registration Number: NCT04124536
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

The overall objective of this study is to evaluate whether the addition of secondary distribution HIV self-test kits to existing partner notification guidelines increases the proportion of male partners who access facility-based HIV testing services, when compared to the partner notification strategy alone

Detailed Description

Pregnant women 18 years of age or older who enter antenatal care at Chipata Level 1 Hospital in Lusaka, Zambia will participate.

HIV-positive and HIV-negative pregnant women will be randomized to one of two groups: partner notification alone or partner notification plus secondary distribution of HIV self-test kits. Women will return to the clinic 30 days after enrollment for an exit visit during which time information about their experience with the partner notification strategies will be collected.

A random sample of women and health care workers will also participate in qualitative interviews.

Study Timeline

• Study Start: 2019-09-03
• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-11
• Primary Completion: 2020-07-03
• Study Completion: 2020-09-07
• Status Verified: 2021-04
• Results First Submitted: 2021-04-29
• Results First Submitted QC: 2021-04-29
• Results First Posted: 2021-05-24
• Last Update Submitted: 2021-06-30
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 341

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	HIV self-testing with partner notification.	In addition to standard partner notification services, the intervention arm will receive HIV self-test kits and structured counseling about HIVST, regardless of HIV status.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility	Enrollment - 30 days post enrollment of study participant	The number of participants who report their primary male partners getting tested for HIV at a healthcare facility when presented with partner notification plus secondary distribution of HIV self-test kits compared to partner notification alone

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Reported HIV Testing With Primary Male Partner at a Healthcare Facility	Enrollment - 30 days post enrollment of study participant	The number of couples getting tested for HIV when presented with partner notification plus secondary distribution of HIV self-test kits will be compared to partner notification alone.
Number of Participants Reporting Social Harms	Enrollment - 30 days post enrollment of study participant	The number of participants reporting social harms associated with the HIV testing approaches. Participants were asked about social harms related to trial participation, including perceived stigma, discrimination, and intimate partner violence.
Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative)	6 months after the start of enrollment	To gain deeper insights about the feasibility of male partner HIV testing strategies, healthcare workers from the study site were asked to participate in in-depth interviews. Participating healthcare workers were involved in different aspects of male partner HIV testing and included study staff members. Feasibility was defined as a positive rating about the intervention's potential performance in real-life conditions at the clinic and community levels.
Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative)	In the first two months of enrollment	To gain deeper insights about the acceptability of the different male partner HIV testing strategies, subsamples of participants were selected based on study arm (intervention vs. control) and woman's HIV status (positive vs. negative). For the outcome measure, acceptability was defined as a positive rating of male partner HIV testing strategies from participants based on their experiences.

Trial Locations

Locations (1)

Chipata Health Centre; 🇿🇲 Lusaka, Zambia