Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe

NCT06226155 | Recruiting DMC

• 1 other identifier: 2023P003607
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop a multi-level PrEP adherence and persistence intervention as an adaptation of the TENDAI ('grateful' in Shona) program, a problem-solving approach to reduce depression and increase HIV treatment adherence among people living with HIV in Zimbabwe. The new intervention, TENDAI4PrEP, will be designed to improve PrEP uptake and persistence among pregnant persons in Zimbabwe. If feasibility, acceptability, and preliminary efficacy are demonstrated, the intervention will be ready for large-scale effectiveness/implementation testing. This program will has the potential to address a critical public health challenge impacting pregnant and postpartum persons in Zimbabwe: the prevention of HIV acquisition and transmission.

Conditions

HIV Infections; Pregnancy Related; Depression, Anxiety

Outcome Measures

Primary Outcomes (4)

• Feasibility (patient level)

  Assessed by (1) 75% of the participants attended at least half of all treatment sessions (2) 80% of the reviewed treatment sessions addressed all key themes, and (3) 60% of the participants completed the assessments at T2 and T3.

  T3 (5 months post-baseline)

• Acceptability (patient level)

  Assessed via the brief health care interventions framework questionnaire; on average, at least 75% of the participants rate four or more of the items on the postsession acceptability questionnaires with a 4 or a 5 on the Likert-style scale. Scores vary from 1-5, with a higher score indicating higher acceptability.

  T3 (5 months post-baseline)

• Feasibility (provider level)

  Feasibility will be demonstrated if (1) at least 70% of the antenatal clinic providers attend the group sessions and (2) a review of the audio recording indicates that all key themes were addressed.

  T3 (5 months post-baseline)

• Acceptability (provider level)

  Assessed via the brief health care interventions framework questionnaire; the sessions will be deemed acceptable if, on average, at least 75% of the providers rate four or more of the items on the post-session acceptability questionnaires with a 4 or a 5 on the Likert-style scale. Scores vary from 1-5, with a higher score indicating higher acceptability.

  T3 (5 months post-baseline)

Secondary Outcomes (5)

• Self-reported PrEP adherence (patient level)

  T2 (2 months post-baseline)

• Psychological distress (patient level)

  T2 (2 months post-baseline)

• PrEP persistence (patient level)

  T3 (5 months post-baseline)

• Change in PrEP knowledge (provider level)

  Baseline, T3 (5 months post-baseline)

• Change in PrEP stigma (provider level)

  Baseline, T3 (5 months post-baseline)

Study Arms (2)

TENDAI4PrEP

EXPERIMENTAL

TENDAI4PrEP problem-solving intervention will likely entail 4-5 sessions, inclusive of the dyadic session with a partner, with an optional postpartum booster session. The intervention will involve PrEP education and psychoeducation, Nzira Itsva (a culturally adapted Life Steps intervention), and problem-solving therapy.

Behavioral: TENDAI4PrEP

Enhanced Treatment as Usual (ETAU)

ACTIVE COMPARATOR

Participants randomized to ETAU will receive care as usual, which is monthly visits to the ANC, plus a pamphlet of information that describes PrEP efficacy, safety during pregnancy/postpartum, and PrEP availability at the ANC. Antenatal treatment as usual will also be enhanced at the clinic level through the provider-level training, which will be offered to all clinic staff in a nonrandomized design. ETAU participants will also be referred for psychological services at the hospital.

Other: Enhanced treatment as usual

Interventions

TENDAI4PrEP BEHAVIORAL

An adapted problem-solving PrEP use intervention for HIV negative pregnant persons living with psychological distress, their partners, and antenatal care providers.

TENDAI4PrEP

Enhanced treatment as usual OTHER

Includes monthly visits to the ANC plus a pamphlet of information that describes PrEP efficacy. safety during pregnancy/postpartum, and PrEP availability at the ANC.

Enhanced Treatment as Usual (ETAU)

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Across all aims participants must be
• Pregnant
• Presenting at the Chitungwiza Central Hospital ANC
• Aged 15+
• Willing to provide informed consent or assent
• Have HIV negative status
• At risk for HIV acquisition (defined as having a male partner of unknown HIV status, suspicions of partner infidelity, reporting multiple partners, or history of STI and/or recent condomless sexual activity)
• Score \>5 on the Shona Symptom Questionnaire
• For the RCT, eligible participants must also be willing to
• Initiate PrEP prior to randomization
• Bring their pregnancy partner (if they are safe doing so).

You may not qualify if:

• Inability to provide informed consent/assent and/or complete procedures in Shona or English
• Current interfering untreated or unstable mental health condition that precludes functional involvement in the study (e.g., active psychosis, untreated bipolar disorder)

Sponsors & Collaborators

• University of Zimbabwe: collaborator
• Boston University: collaborator
• Massachusetts General Hospital: lead

Study Sites (1)

University of Zimbabwe

Harare, Zimbabwe

RECRUITING

MeSH Terms

Conditions

HIV Infections; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Amelia M Stanton, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

• Walter Mangezi, MD

  University of Zimbabwe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Conall O'Cleirigh

CONTACT

617-643-0385; cocleirigh@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Behavioral Medicine / Associate Professor

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: NDA will make decisions about how long to preserve the data; however, NDA has not deleted any deposited data as to date. Data will be deposited every 6 months.
• Access Criteria: Those accessing this dataset must register through NDA and agree to the Terms of Use. Users must agree to not re-disseminate data, use appropriate data citation, and to maintain human subjects' protections. The standard NDA data process allows access for one year and is renewable.

Locations

ZI (1)