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

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT04330989

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

300

Enrollment

Location

Arms

23.4

Actual Duration (Months)

12.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV-1-infection Antenatal Care	Behavioral: iNSC and Adherence supporter training	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 1, 2020

Actual Primary Completion Date :

Feb 10, 2022

Actual Study Completion Date :

Feb 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
No Intervention: Group 1b: Standard of Care HIV-positive participants randomly assigned to the control arm will antiretroviral 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.	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.
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).

Outcome Measures

Primary Outcome Measures

Group 2 (ART adherence support) [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) [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.
Acceptability [6 months following study enrollment]
Measured via semi-structured interviews and longitudinal questionnaires about the different intervention components
Fidelity [6 months following study enrollment]
Measured via audits of recorded counseling sessions

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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