Back to resultsCombination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women (MP3 Pilot)
Primary Purpose
HIV
Status
Completed
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
HIV self-testing with partner notification.
Sponsored by
About this trial
This is an interventional diagnostic trial for HIV focused on measuring Self Testing, Partner notification, Secondary Distribution
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.
Sites / Locations
- Chipata Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
Standard partner notification services, regardless of HIV status.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT04124536
First Posted
October 9, 2019
Last Updated
June 30, 2021
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT04124536
Brief Title
Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women
Acronym
MP3 Pilot
Official Title
Z 31901 - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
July 3, 2020 (Actual)
Study Completion Date
September 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
Self Testing, Partner notification, Secondary Distribution
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
341 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard partner notification services, regardless of HIV status.
Intervention Type
Behavioral
Intervention Name(s)
HIV self-testing with partner notification.
Intervention Description
HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm, regardless of HIV status.
Primary Outcome Measure Information:
Title
Number of Participants Who Reported Primary Male Partner Completed HIV Testing at a Healthcare Facility
Description
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
Time Frame
Enrollment - 30 days post enrollment of study participant
Secondary Outcome Measure Information:
Title
Number of Participants Who Reported HIV Testing With Primary Male Partner at a Healthcare Facility
Description
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.
Time Frame
Enrollment - 30 days post enrollment of study participant
Title
Number of Participants Reporting Social Harms
Description
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.
Time Frame
Enrollment - 30 days post enrollment of study participant
Title
Number of Healthcare Providers Describing Feasibility of Intervention Via In-depth Interviews (Qualitative)
Description
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.
Time Frame
6 months after the start of enrollment
Title
Number of Participants Describing Acceptability of Intervention Via In-depth Interviews (Qualitative)
Description
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.
Time Frame
In the first two months of enrollment
Other Pre-specified Outcome Measures:
Title
Number of Participants Who Reported Primary Male Partner HIV Testing Completed at Any Venue
Description
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
Time Frame
Enrollment - 30 days post enrollment of study participant
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Chi, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chipata Health Centre
City
Lusaka
Country
Zambia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD Sharing Time Frame
9 to 36 months following publication
IPD Sharing Access Criteria
IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.
Citations:
PubMed Identifier
34735862
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.
Results Reference
derived
Learn more about this trial
Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women
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