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Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women (MP3 Pilot)

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ClinicalTrials.gov Identifier: NCT04124536
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
The overall objective of this study is to evaluate whether the addition of secondary distribution HIV self-test kits (SD-HIVST) to existing partner notification guidelines increases the proportion of male partners who access facility-based HIV testing services (HTS), when compared to the partner notification strategy alone

Condition or disease Intervention/treatment Phase
HIV Behavioral: HIV self-testing with partner notification. Not Applicable

Detailed Description:

Pregnant women 18 years of age or older who enter antenatal care (ANC) 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 (SD-HIVST). 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Z 31901 - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women: A Pilot Study
Actual Study Start Date : September 3, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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

No Intervention: Control
Standard partner notification services, regardless of HIV status.



Primary Outcome Measures :
  1. Proportion of primary male partners who complete facility-based HTS by participant self-report [ Time Frame: Enrollment - 30 days post enrollment of study participant ]
    The number of male partners getting tested for HIV when presented with partner notification plus SD-HIVST will be compared to partner notification alone


Secondary Outcome Measures :
  1. Proportion of couples (pregnant woman and partner) who receive facility-based HTS together. [ Time Frame: Enrollment - 30 days post enrollment of study participant ]
    The number of couples getting tested for HIV when presented with partner notification plus SD-HIVST will be compared to partner notification alone.

  2. Incidence of social harms [ Time Frame: Enrollment - 30 days post enrollment of study participant ]
    The rate of social harms and other adverse events associated with the HIV testing approaches

  3. Feasibility - Qualitative summaries of healthcare worker experiences from in-depth interviews [ Time Frame: 6 months after the start of enrollment ]
    Experiences with providing partner HIV testing, including patient preferences, perceived benefits and harms, and health systems burden

  4. Acceptability - Qualitative summaries of participant experience from in-depth interviews [ Time Frame: within 2 months of enrollment ]
    Experiences with partner HIV testing, including use of HIV self-test kits (intervention arm), and how it affected partner relationships


Other Outcome Measures:
  1. HIV testing rates among secondary male partners [ Time Frame: Enrollment - 30 days post enrollment ]
    The number of secondary male partners getting HIV tested when presented with partner notification plus SD-HIVST will be compared to partner notification alone



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124536


Contacts
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Contact: Margaret Kasaro 260 967 780 284 margaret.kasaro@unclusaka.org

Locations
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Zambia
Chipata Health Centre Recruiting
Lusaka, Zambia
Contact: Kellie Freeborn    260 967 780 284    kellie.freeborn@med.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Ben Chi, MD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04124536     History of Changes
Other Study ID Numbers: 19-0276
R01AI131060 ( U.S. NIH Grant/Contract )
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Self Testing
Partner notification
Secondary Distribution
Additional relevant MeSH terms:
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HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases