Clinical trial NCT04330989: An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-1-infection
Antenatal Care
Keywords: HIV Transmission
Antiretroviral Treatment
Pre-exposure Prophylaxis
Patient-centered Counseling
Adherence Supporter Training
Antenatal Care
HIV
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-04-02
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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 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

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 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

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

Primary outcomes:
measure: Number of Participants Retained in Care With HIV Viral Suppression <40 Copies/mL (Groups 1a and 1b Only)
timeFrame: 6 months following study enrollment
measure: Number of Participants Retained in Care With Functional Adherence to PrEP (Groups 2a and 2b Only)
timeFrame: 6 months following study enrollment
Secondary outcomes:
measure: Fidelity Score Indicating How Counselors Correctly Delivered Integrated Next Step Counseling by Session
timeFrame: 6 months following study enrollment
measure: Reported Level of Satisfaction by Participants for the Study Intervention
timeFrame: 6 months following study enrollment
measure: Number of Participants Retained in Care With HIV Viral Suppression <1000 Copies/mL (Groups 1a and 1b Only)
timeFrame: 6 months following study enrollment
measure: Number of Participants Retained in Care With ART Adherence >95% Over the Last 30 Days (Groups 1a and 1b Only)
timeFrame: 6 months following study enrollment
measure: Number of Participants Retained in Care With >95% Adherence to PrEP Over Last 30 Days (Groups 2a and 2b Only)
timeFrame: 6 months following study enrollment
measure: Number of Participants Reporting Social Harms
timeFrame: 3 months following study enrollment
measure: Number of Participants Reporting Social Harms
timeFrame: 6 months following study enrollment
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Bwaila District Hospital
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Benjamin Chi, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.