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Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya (Jamii Bora)

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ClinicalTrials.gov Identifier: NCT03547739
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : April 1, 2019
Sponsor:
Collaborators:
Kenya Medical Research Institute
University of Michigan
University of Witwatersrand, South Africa
University of Pennsylvania
Information provided by (Responsible Party):
Janet M. Turan, PhD, University of Alabama at Birmingham

Brief Summary:
This study will test the efficacy and cost-effectiveness of an interdependence theory-based couples intervention in Kenya that reaches pregnant women and male partners through home visits by male-female pairs of lay health workers, and includes offer of home-based CHTC services.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Behavioral: Home visits Behavioral: HIV Self-testing Not Applicable

Detailed Description:
Despite the potential for antiretroviral therapy to improve maternal health and reduce mother-to-child transmission of HIV to as low as 1%, HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa. This is particularly true in Kenya, where crucial drop-offs occur in the cascade of prevention of mother-to-child transmission (PMTCT) services. Weak health systems contribute to insufficient service coverage, but many barriers lie beyond the clinic—in the partner, family, and community factors that shape women's health decisions. The investigators' research in a high HIV prevalence area of southwestern Kenya has shown that many women avoid couples HIV testing and do not adhere to PMTCT regimens because they fear negative consequences from a male partner. Men can play a crucial supportive role for family health, but male partners in Kenya are poorly engaged in antenatal care and uptake of couples HIV testing during pregnancy is low. Pregnant women desire to be tested for HIV together with their partner and need the support for mutual disclosure involved in couples HIV testing and counseling (CHTC), regardless of whether they know their own HIV status. In this context, the investigators will test the efficacy of an interdependence theory-based couples intervention that reaches pregnant women and male partners through home visits by male-female pairs of lay health workers, and includes offer of home-based CHTC services. The randomized pilot study of this intervention with 96 pregnant couples (R34MH102103) demonstrated significant increases in uptake of couples testing (64% in intervention vs. 23% in control, p<0.001) and significant improvements in health behaviors such as exclusive breastfeeding and postpartum care. The investigators will now conduct a more robust investigation to determine whether this intervention improves uptake of couples HIV testing and health outcomes over and above less intensive male engagement strategies being used in the region. This theory-based couples intervention has strong potential to increase couple HIV testing and collaboration for family health. The study will inform decision-makers about cost-effective strategies to engage pregnant couples in PMTCT and family health, with important downstream benefits for maternal, paternal, and infant health.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Home visits
Participants randomized to intervention arm receive 5 home visits conducted by one female and one male lay health worker.
Behavioral: Home visits
If a couple has been randomized to the home visit intervention arm, a lay health worker will obtain detailed locator information (including cell phone contacts) and consult with the couple about optimal times for a home visit. As described above, the intervention arm will consist of five home visits conducted by one female and one male lay health worker, including two home visits during pregnancy, one at six weeks after the birth, and two booster sessions, one at six months after the birth and one at 12 months after the birth. Home visits are designed for all pregnant couples (regardless of woman's initial HIV test result at the antenatal clinic) and include topics important for maternal, paternal, and child health during pregnancy and postpartum.

Active Comparator: HIV Self-testing
Women in this study group will receive HIV self-test kits for themselves and their male partner at up to 4 time points.
Behavioral: HIV Self-testing
Women in this study group will receive oral-fluid-based rapid HIV test kits for themselves and their male partner at up to 4 time points (twice during pregnancy and twice postpartum). Each test will be accompanied with a self-testing instruction sheet describing step-by-step procedures in multiple languages. Study staff will also conduct a brief demonstration on how to use the tests. Participants will be encouraged to offer a test kit to their male partner or to undertake couples testing. They will also be counseled on how to talk to their partners and the possibility of adverse partner reactions. Participants will be instructed to seek clinic-based confirmatory testing if a reactive self-test result is obtained.

No Intervention: Standard Care
Participants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or Couples HIV Counseling and Testing (CHCT).



Primary Outcome Measures :
  1. Change in couple HIV testing uptake from baseline to 12 months postpartum (all couples) [ Time Frame: Baseline, 3 months postpartum, 12 months postpartum ]
    Change in couples HIV testing uptake during observation period (from baseline to 12 months postpartum), coded as Y/N. This is assessed in the questionnaires for all couples regardless of HIV status at baseline and each follow-up until 12 months postpartum and confirmed through medical records.


Secondary Outcome Measures :
  1. HIV re-testing [ Time Frame: Baseline, 3 months postpartum, 12 months postpartum ]
    Re-testing for HIV during pregnancy and postpartum during observation period assessed in the questionnaire and confirmed through medical records, completed by all participants at baseline and each follow-up until 12 months postpartum.

  2. Number of new male HIV-positive diagnoses [ Time Frame: Baseline, 3 months postpartum, 12 months postpartum ]
    Number of new HIV-positive test results of male partners during observation period, coded as Y/N. This is assessed for all male participants at baseline and each follow-up until 12 months postpartum in the questionnaires and confirmed through medical records.

  3. Number of new discordant couples [ Time Frame: Baseline, 3 months postpartum, 12 months postpartum ]
    Number of new HIV serodiscordant couples identified during observation period. This is assessed for all couples at baseline and each follow-up until 12 months postpartum in the questionnaires and confirmed through medical records.

  4. Use of PMTCT interventions (for HIV-positive women only) [ Time Frame: 3 months postpartum, 12 months postpartum, 18 months postpartum ]
    Composite variable including mothers use of antiretrovirals (ARVs) (Y/N), prophylactic ARVs given to the infant (Y/N), and appropriate infant feeding practices. These are assessed in the questionnaires completed at each follow-up up to 18 month postpartum.

  5. Utilization of maternal and child health (MCH) services (all couples in the study) [ Time Frame: 3 months postpartum, 12 months postpartum, 18 months postpartum ]
    Composite variable including at having completed least four antenatal care (ANC) visits during pregnancy (Y/N), childbirth with a skilled attendant (Y/N), and postnatal check-ups for woman (Y/N) and infant (Y/N). These are assessed in the follow-up questionnaires completed up to 18 months postpartum.

  6. Pre-Exposure Prophylaxis (PrEP) uptake (discordant partners at follow-ups) [ Time Frame: 3 months postpartum, 12 months postpartum, 18 months postpartum ]
    Initiation of PrEP by discordant partners assessed at each follow-up in the questionnaires and confirmed through through medical records up to 18 months after the baby's birth.

  7. Woman's linkage to HIV care (HIV-positive women) [ Time Frame: Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum ]
    Time to linkage to HIV care assessed for HIV-positive women at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records.

  8. Woman's enrollment in HIV care (HIV-positive women) [ Time Frame: Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum ]
    Enrollment of HIV-positive women in HIV care (Y/N) assessed at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records.

  9. Woman's adherence to HIV care (HIV-positive women) [ Time Frame: Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum ]
    Self-reported adherence to HIV care assessed for HIV-positive women at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records.

  10. Number of HIV care visits (HIV-positive women) [ Time Frame: Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum ]
    Number of HIV care visits assessed for HIV-positive women at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records.

  11. Man's linkage to HIV care (HIV-positive men) [ Time Frame: Baseline, 3 months after baby's birth, 12 months after baby's birth, 18 months after baby's birth ]
    Time to linkage to HIV care assessed for HIV-positive men at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records.

  12. Man's enrollment in HIV care (HIV-positive men) [ Time Frame: Baseline, 3 months after baby's birth, 12 months after baby's birth, 18 months after baby's birth ]
    Enrollment of HIV-positive men in HIV care (Y/N) assessed at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records.

  13. Man's adherence to HIV care (HIV-positive men) [ Time Frame: Baseline, 3 months after baby's birth, 12 months after baby's birth, 18 months after baby's birth ]
    Self-reported adherence to HIV care assessed for HIV-positive men at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records.

  14. Number of HIV care visits (HIV-positive men) [ Time Frame: Baseline, 3 months after baby's birth, 12 months after baby's birth, 18 months after baby's birth ]
    Number of HIV care visits assessed for HIV-positive men at baseline and in the follow-up questionnaires completed up to 18 months postpartum and confirmed through medical records.

  15. Maternal HIV viral suppression (HIV-positive women) [ Time Frame: Baseline, 3 months postpartum, 12 months postpartum, 18 months postpartum ]
    Viral Load < 200 copies (undetectable) for all HIV-positive women at baseline and 18 months postpartum through medical records.

  16. HIV-free child survival [ Time Frame: 18 months after the birth ]
    Child alive and HIV-free at 18 months after the birth. This is assessed in a brief interview and confirmed through medical records.

  17. Result of infant HIV test [ Time Frame: 3 months after birth, 12 months after birth, 18 months after birth ]
    Result of infant HIV test based on medical records.

  18. Date of infant HIV test [ Time Frame: 3 months after birth, 12 months after birth, 18 months after birth ]
    Date of infant HIV test based on medical records.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women at 36 weeks of pregnancy or less
  • 15 years of age or older
  • Has been offered HIV testing at ANC
  • Is currently in a stable relationship with a male partner and living with that male partner - Has not yet participated in couple HIV testing during this pregnancy.
  • Male partner is the person identified by the pregnant woman as her primary male partner and should also be 15 years of age or older.
  • Not in an HIV-positive concordant relationship.

Exclusion Criteria:

  • Greater than 36 weeks of pregnancy
  • Less than 15 years of age
  • Not currently in a stable relationship with a male partner
  • Does not currently live with male partner
  • Has not been offered HIV testing at ANC

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): NCT03547739


Contacts
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Contact: Janet M Turan, PhD, MPH 2059346780 jmturan@uab.edu

Locations
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Kenya
Kenya Medical Research Institute Recruiting
Nairobi, Kenya
Contact: Zachary Kwena, PhD    2540733333005    zkwena@kemri-ucsf.org   
Principal Investigator: Zachary Kwena, PhD         
Sub-Investigator: Elizabeth Bukusi, MBChB, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
Kenya Medical Research Institute
University of Michigan
University of Witwatersrand, South Africa
University of Pennsylvania
Investigators
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Principal Investigator: Janet M Turan, PhD, MPH University of Alabama at Birmingham
Principal Investigator: Lynae Darbes, PhD University of Michigan

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Responsible Party: Janet M. Turan, PhD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03547739     History of Changes
Other Study ID Numbers: IRB-300001427
000518108 ( Other Identifier: UAB Office of Sponsored Programs )
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases