Clinical trial NCT04124536: Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women
Official title: Z 31901 - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Self Testing
Partner notification
Secondary Distribution
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2019-10-11
Enrollment: 341
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility
timeFrame: Enrollment - 30 days post enrollment of study participant
Secondary outcomes:
measure: Number of Participants Who Reported HIV Testing With Primary Male Partner at a Healthcare Facility
timeFrame: Enrollment - 30 days post enrollment of study participant
measure: Number of Participants Reporting Social Harms
timeFrame: Enrollment - 30 days post enrollment of study participant
measure: Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative)
timeFrame: 6 months after the start of enrollment
measure: Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative)
timeFrame: In the first two months of enrollment
Other outcomes:
measure: Number of Participants Who Reported Primary Male Partner HIV Testing Completed at Any Venue
timeFrame: Enrollment - 30 days post enrollment of study participant
Locations:
city: Lusaka
country: Zambia
facility: Chipata Health Centre
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ben Chi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mutale W, Freeborn K, Graybill LA, Lusaka MM, Mollan KR, Mweemba O, Kasaro M, Lungu R, Kumwenda A, Saidi F, Powers KA, Maman S, Rosenberg NE, Chi BH. Addition of HIV self-test kits to partner notification services to increase HIV testing of male partners of pregnant women in Zambia: two parallel randomised trials. Lancet Glob Health. 2021 Dec;9(12):e1719-e1729. doi: 10.1016/S2214-109X(21)00393-4. Epub 2021 Nov 1.