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Completed

NCT Number: NCT04124536

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

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

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Key information

Conditions

HIV

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chipata Health Centre

Lusaka, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Number of Participants Reporting Social Harms

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Other outcomes

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

    Time frame: Enrollment - 30 days post enrollment of study participant

    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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Acronym: MP3 Pilot

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 11, 2019
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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