Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 9, 2019
First Posted Date  ICMJE October 11, 2019
Last Update Posted Date November 13, 2019
Actual Study Start Date  ICMJE September 3, 2019
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04124536 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
  • 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.
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 10, 2019)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women
Official Title  ICMJE Z 31901 - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women: A Pilot Study
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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE HIV
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: HIV self-testing with partner notification.
  • No Intervention: Control
    Standard partner notification services, regardless of HIV status.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2019)
336
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnant women
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Margaret Kasaro 260 967 780 284 margaret.kasaro@unclusaka.org
Listed Location Countries  ICMJE Zambia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04124536
Other Study ID Numbers  ICMJE 19-0276
R01AI131060 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Principal Investigator: Ben Chi, MD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP