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

NCT04330989 | Completed Results

• 3 other identifiers: 19-1060R01AI131060UNCPMZ 41901
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV-1-infection; Antenatal Care

Keywords

HIV Transmission; Antiretroviral Treatment; Pre-exposure Prophylaxis; Patient-centered Counseling; Adherence Supporter Training; Antenatal Care; HIV

Outcome Measures

Primary Outcomes (2)

• Number of Participants Retained in Care With HIV Viral Suppression <40 Copies/mL (Groups 1a and 1b Only)

  The primary outcome measure is retention in care with HIV viral suppression, defined as \<40 copies/mL.

  6 months following study enrollment

• Number of Participants Retained in Care With Functional Adherence to PrEP (Groups 2a and 2b Only)

  The primary outcome is retention in care with functional adherence to PrEP as measured categorically according to plasma and intracellular tenofovir drug concentrations.

  6 months following study enrollment

Secondary Outcomes (7)

• Fidelity Score Indicating How Counselors Correctly Delivered Integrated Next Step Counseling by Session

  6 months following study enrollment

• Reported Level of Satisfaction by Participants for the Study Intervention

  6 months following study enrollment

• Number of Participants Retained in Care With HIV Viral Suppression <1000 Copies/mL (Groups 1a and 1b Only)

  6 months following study enrollment

• Number of Participants Retained in Care With ART Adherence >95% Over the Last 30 Days (Groups 1a and 1b Only)

  6 months following study enrollment

• Number of Participants Retained in Care With >95% Adherence to PrEP Over Last 30 Days (Groups 2a and 2b Only)

  6 months following study enrollment

Study Arms (4)

Group 1a: iNSC and Adherence supporter training

EXPERIMENTAL

HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART.

Behavioral: iNSC and Adherence supporter training

Group 1b: Standard of Care

NO INTERVENTION

HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm).

Group 2a: iNSC and Adherence supporter training

EXPERIMENTAL

HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP.

Behavioral: iNSC and Adherence supporter training

Group 2b: Standard of Care

NO INTERVENTION

HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm).

Interventions

iNSC and Adherence supporter training BEHAVIORAL

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.

Group 1a: iNSC and Adherence supporter training; Group 2a: iNSC and Adherence supporter training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented pregnancy by urine pregnancy test or physical exam
• Documented positive HIV status
• Initiated on first-line antiretroviral therapy (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

You may not qualify if:

• 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):
• 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 sexually transmitted infection 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 HIV pre-exposure prophylaxis (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
• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Bwaila District Hospital

Lilongwe, Malawi

Location

Related Publications (3)

• Mutale W, Graybill LA, Saidi F, Phanga T, Amico KR, Freeborn K, Rosenberg NE, Hill LM, Hamoonga T, Richardson BD, Mollan KR, Chi BH. Evaluation of a combination adherence strategy to support HIV antiretroviral therapy for pregnancy and breastfeeding in Malawi: A pilot randomized clinical trial. PLoS One. 2025 Apr 28;20(4):e0319735. doi: 10.1371/journal.pone.0319735. eCollection 2025.

  PMID: 40293995 DERIVED

• Chi BH, Saidi F, Graybill LA, Phanga T, Mollan KR, Amico KR, Freeborn K, Rosenberg NE, Hill LM, Hamoonga T, Richardson B, Kalua T, Phiri S, Mutale W. A Patient-Centered, Combination Intervention to Support Adherence to HIV Pre-exposure Prophylaxis During Pregnancy and Breastfeeding: A Randomized Pilot Study in Malawi. J Acquir Immune Defic Syndr. 2024 Jan 1;95(1):42-51. doi: 10.1097/QAI.0000000000003309.

  PMID: 37757844 DERIVED

• Saidi F, Mutale W, Freeborn K, Rosenberg NE, Graybill LA, Maman S, Amico KR, Mollan KR, Phanga T, Milala B, Hill LM, Gottwalt AM, Phiri S, Kalua T, Chi BH. Combination adherence strategy to support HIV antiretroviral therapy and pre-exposure prophylaxis adherence during pregnancy and breastfeeding: protocol for a pair of pilot randomised trials. BMJ Open. 2021 Jun 30;11(6):e046032. doi: 10.1136/bmjopen-2020-046032.

  PMID: 34193491 DERIVED

Results Point of Contact

• Title: Benjamin Chi
• Organization: University of North Carolina at Chapel Hill

bchi@med.unc.edu

9194454147

Study Officials

• Benjamin Chi, MD, MSc

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a parallel pilot randomized trial in which participants randomly assigned to the control arm will receive antiretroviral adherence support about HIV treatment and prevention. Those randomized to the intervention arm will additionally receive a multi-component support strategy comprising integrated next-step counseling (iNSC) and adherence supporter training.

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 2, 2020
• Study Start: March 1, 2020
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: January 11, 2023
• Results First Posted: January 9, 2023

Record last verified: 2022-01

Locations

MA (1)