An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women

Overview

This study is composed of two parallel, pilot randomized groups that will obtain preliminary data about the effectiveness and implementation of a multi-component adherence support strategy for HIV treatment and prevention among pregnant and breastfeeding women. The study will take place in Lusaka, Zambia and Lilongwe, Malawi.

Full Title of Study: “UNCPMZ 41901 – An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women: a Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2021

Detailed Description

If the anticipated gains for the prevention of mother-to-child HIV transmission (PMTCT) programs are to be realized, adherence to antiretroviral regimens will be critical. To date, however, there are few evidence-based approaches that are scalable and sustainable in busy, programmatic settings where HIV burden is high. The study seeks to implement the intervention, which includes patient-centered counseling and adherence supporter training, for both HIV-positive (for antiretroviral therapy, or ART) and HIV-negative (for pre-exposure prophylaxis, or PrEP) pregnant and breastfeeding women, thus providing a universal approach to support PMTCT programs holistically. The study will enroll pregnant women 18 years of age or older receiving antenatal care services at one of the designated study facilities. In Group 1, the study will enroll 100 HIV-positive women who started (or re-started, after a 6 months or longer treatment interruption) a first-line ART regimen within the past 30 days. In Group 2, the study will enroll 200 HIV-negative women willing to initiate and continue oral PrEP, in the form of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC), and who report factors that place them at elevated risk for HIV acquisition.

Interventions

  • Behavioral: iNSC and Adherence supporter training
    • Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.

Arms, Groups and Cohorts

  • Experimental: Group 1a: iNSC and Adherence supporter training
    • HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART.
  • No Intervention: Group 1b: Standard of Care
    • HIV-positive participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm).
  • Experimental: Group 2a: iNSC and Adherence supporter training
    • HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP.
  • No Intervention: Group 2b: Standard of Care
    • HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm).

Clinical Trial Outcome Measures

Primary Measures

  • Group 2 (ART adherence support)
    • Time Frame: 6 months following study enrollment
    • The primary outcome measure is retention in care with HIV viral suppression, defined as <40 copies/mL.
  • Group 2 (PrEP adherence support)
    • Time Frame: 6 months following study enrollment
    • The primary outcome is retention in care with functional adherence to PrEP as measured categorically according to plasma and intracellular tenofovir drug concentrations.

Participating in This Clinical Trial

Eligibility criteria for enrollment in Group 1 (HIV-positive women):

Inclusion Criteria

  • Documented pregnancy by urine pregnancy test or physical exam
  • Documented positive HIV status
  • Initiated on first-line ART within the past 30 days, either for the first time or after treatment interruption of 6 months or longer (if previously started but stopped ART)
  • Willingness to remain in the study site's catchment area over the course of study follow-up and to comply with visit schedule
  • Ability and willingness to provide informed consent

Exclusion Criteria

  • Risk for intimate partner violence or social harms as a result of participation, in the judgement of the study personnel
  • Other conditions that, in the judgment of the study personnel, would make participation in the study inappropriate

Eligibility criteria for enrollment in Group 2 (HIV-negative women):

Inclusion Criteria

  • Documented pregnancy by urine pregnancy test or physical exam
  • Documented negative HIV status within the past three months
  • Identified factor(s) for elevated risk for HIV acquisition, such as known positive or unknown partner HIV status; report of secondary sexual partners over the past 12 months; diagnosis of STI over the past 12 months; use of post-exposure prophylaxis in the past 12 months; reported use of shared injection material or equipment; and/or unspecified concern about HIV acquisition during pregnancy and breastfeeding
  • Willingness to initiate and continue PrEP over the course of study follow-up
  • Willingness to remain in the study site's catchment area over the course of study follow-up and to comply with visit schedule
  • Ability and willingness to provide informed consent

Exclusion Criteria

  • Positive HIV test at time of screening
  • Positive hepatitis B surface antigen test at time of screening
  • Renal insufficiency, defined as creatinine clearance <90 mL/min, history of known renal parenchymal disease, or known single kidney at time of screening
  • Risk for intimate partner violence or social harms as a result of participation, in the judgement of the study personnel
  • Other conditions that, in the judgment of the study personnel, would make participation in the study inappropriate

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of North Carolina, Chapel Hill
  • Collaborator
    • National Institute of Allergy and Infectious Diseases (NIAID)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Benjamin Chi, MD, MSc, Principal Investigator, University of North Carolina, Chapel Hill
  • Overall Contact(s)
    • Friday Saidi, MD, 265 995 403 113, fsaidi@unclilongwe.org

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