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

NCT04124536 | Completed Results

• 2 other identifiers: 19-0276R01AI131060
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 1

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

Conditions

HIV

Keywords

Self Testing; Partner notification; Secondary Distribution

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants Who Reported HIV Testing With Primary Male Partner at a Healthcare Facility

  Enrollment - 30 days post enrollment of study participant

• Number of Participants Reporting Social Harms

  Enrollment - 30 days post enrollment of study participant

• Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative)

  6 months after the start of enrollment

• Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative)

  In the first two months of enrollment

Other Outcomes (1)

• Number of Participants Who Reported Primary Male Partner HIV Testing Completed at Any Venue

  Enrollment - 30 days post enrollment of study participant

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: HIV self-testing with partner notification.

Control

NO INTERVENTION

Standard partner notification services, regardless of HIV status.

Interventions

HIV self-testing with partner notification. BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Chipata Health Centre

Lusaka, Zambia

Location

Related Publications (1)

• 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.

  PMID: 34735862 DERIVED

MeSH Terms

Interventions

Contact Tracing

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Public Health; Environment and Public Health; Communicable Disease Control; Public Health Practice

Results Point of Contact

• Title: Benjamin Chi, MD, MSc
• Organization: University of North Carolina at Chapel Hill

bchi@med.unc.edu

919-445-4174

Study Officials

• Ben Chi, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 11, 2019
• Study Start: September 3, 2019
• Primary Completion: July 3, 2020
• Study Completion: September 7, 2020
• Last Updated: July 21, 2021
• Results First Posted: May 24, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 to 36 months following publication
• Access Criteria: IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.

Locations

ZA (1)