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

HIV Clinical Trial

— MP3 Pilot  

Official title:

Z 31901 - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04124536
• Other study ID #: 19-0276
• Secondary ID: R01AI131060
• Status: Completed
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: September 7, 2020

Study information

• Verified date: April 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: September 7, 2020
• Est. primary completion date: July 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria

• 18 years of age or older
• Pregnant at time of enrollment based on antenatal record
• Documented HIV status (either positive or negative) in antenatal record
• Reports at least one current sexual partner
• Willingness to provide her own contact information
• Ability and willingness to provide informed consent
• Intent to remain in current geographical area of residence for the duration of follow-up activities
• Willingness to adhere to study procedures Exclusion Criteria
• Women who express concerns about IPV or social harms as a result of participation during the screening process will not be included.
• Women who have previously enrolled in the study will not be permitted to enroll again.

Related Conditions & MeSH terms

• HIV
• HIV Seropositivity

Intervention

Behavioral:
• HIV self-testing with partner notification.
HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm, regardless of HIV status.

Locations

Country	Name	City	State
Zambia	Chipata Health Centre	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Who Reported Primary Male Partner HIV Testing Completed at Any Venue	The number of participants who report their primary male partners getting tested for HIV at any venue when presented with partner notification plus secondary distribution of HIV self-test kits (SD-HIVST) compared to partner notification alone	Enrollment - 30 days post enrollment of study participant
Primary	Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility	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	Enrollment - 30 days post enrollment of study participant
Secondary	Number of Participants Who Reported HIV Testing With Primary Male Partner at a Healthcare Facility	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.	Enrollment - 30 days post enrollment of study participant
Secondary	Number of Participants Reporting Social Harms	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.	Enrollment - 30 days post enrollment of study participant
Secondary	Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative)	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.	6 months after the start of enrollment
Secondary	Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative)	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.	In the first two months of enrollment