- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06226155
Adaptation of an Intervention Addressing Barriers to PrEP Use Among Pregnant Women in Zimbabwe (TENDAI4PrEP)
TENDAI4PrEP: Adaptation of a Problem-solving Intervention to Address Individual and Provider Level Barriers to PrEP Uptake and Adherence Among Pregnant Women in Zimbabwe
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Zimbabwe's HIV prevalence rate is among the highest globally, and cisgender women of reproductive age are disproportionately affected. Considering the increased risk of HIV acquisition and transmission during pregnancy, there is an urgent public health need to develop interventions that increase the use of efficacious HIV prevention strategies like PrEP in the antenatal context. Oral pre-exposure prophylaxis (PrEP) is safe during pregnancy, effective in preventing HIV, and available in Zimbabwean antenatal care (ANC) clinics. However, PrEP use remains low among cisgender women of reproductive age. Individual-, interpersonal/community-, and provider-level barriers (e.g., psychological distress, stigma, low partner support, limited PrEP knowledge in providers) compromise use.
A multi-level, problem-solving intervention that addresses barriers to PrEP adherence and persistence during pregnancy and through the postpartum transition among patients, their partners, and antenatal care providers could improve the health of pregnant persons, ultimately decreasing HIV incidence in Zimbabwe.
The aims of this study are as follows:
Aim 1: Explore the impact of intersecting, multi-level barriers on PrEP uptake, adherence, and persistence during pregnancy (n=30), and explore barriers to PrEP provision among antenatal care providers (8-10). In individual interviews with HIV-negative pregnant women with psychological distress (15 PrEP naïve, 15 PrEP experienced), the investigators will probe individual, interpersonal/community, and structural barriers/facilitators. It is anticipated that barriers to uptake, adherence, and persistence may include distress linked to common mental health challenges (e.g., depressed mood, posttraumatic stress) at the individual level; lack of support from partners and providers, stigma, and low PrEP awareness at the interpersonal/community level; and limited access to PrEP care and food insecurity/poverty at the structural level. Among providers, interviews will explore PrEP knowledge, perspectives on HIV prevention during pregnancy, and barriers to prescribing PrEP.
Aim 2: Specify the manual and conduct a small proof-of-concept trial with patients (n=5), their partners (n=5), and providers (n=2). The new manual will teach skills to navigate resources and problem solve the multi-level barriers to PrEP use identified in Aim 1 and will include a group-based training for all providers (education on PrEP during pregnancy, negative PrEP attitudes/stigma, and other barriers to prescribing). Content of the manual will be interactively refined on five participants, their partners, and two providers.
Aim 3a: Evaluate the feasibility and acceptability of the patient-level intervention in a pilot RCT (n=70). PrEP eligible pregnant persons with motivation to initiate PrEP who are experiencing psychological distress will be randomized to either the intervention or to enhanced treatment as usual (mental health referral). Primary outcomes will be feasibility and acceptability; it is hypothesized that the intervention (~4-5 sessions, including one dyadic session with a partner, plus a postpartum booster) will be both feasible and acceptable. Aim 3b: Evaluate the feasibility and acceptability of the provider training (~2 sessions), which will be offered to all providers (n~10) in a nonrandomized design; it is hypothesized that the training will be feasible and acceptable. Aim 3c: Explore perceptions of key implementation outcomes among providers and other administrators (n=15) through individual qualitative exit interviews.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Conall O'Cleirigh
- Phone Number: 617-643-0385
- Email: cocleirigh@mgh.harvard.edu
Study Locations
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-
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Harare, Zimbabwe
- University of Zimbabwe
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Contact:
- Walter Mangezi, MD
- Phone Number: +263712606560
- Email: wmangezi@yahoo.co.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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).
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TENDAI4PrEP
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.
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An adapted problem-solving PrEP use intervention for HIV negative pregnant persons living with psychological distress, their partners, and antenatal care providers.
|
Active Comparator: Enhanced Treatment as Usual (ETAU)
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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility (patient level)
Time Frame: T3 (5 months post-baseline)
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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.
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T3 (5 months post-baseline)
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Feasibility (provider level)
Time Frame: T3 (5 months post-baseline)
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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.
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T3 (5 months post-baseline)
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Acceptability (patient level)
Time Frame: T3 (5 months post-baseline)
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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.
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T3 (5 months post-baseline)
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Acceptability (provider level)
Time Frame: T3 (5 months post-baseline)
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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.
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T3 (5 months post-baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PrEP persistence (patient level)
Time Frame: T3 (5 months post-baseline)
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Determined via DBS and defined as tenofovir-diphosphate (TVF-DP) concentrations of at least 650 fmol/punch for pregnant women and 1050 fmol/punch for postpartum women, indicative of 7 doses per week over a period of up to eight weeks.
This threshold may be adjusted pending new data; pregnancy appears to alter the pharmacokinetics of oral PrEP such that differences in TVF-DP levels may be as great as 30-40% between pregnant and postpartum women.
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T3 (5 months post-baseline)
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Self-reported PrEP adherence (patient level)
Time Frame: T2 (2 months post-baseline)
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Assessed at T2 via an adapted version of the Wilson three-item self-report adherence scale.This is a 0-100 scale with 0 representing the lowest possible adherence and 100 representing the highest adherence.
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T2 (2 months post-baseline)
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Psychological distress (patient level)
Time Frame: T2 (2 months post-baseline)
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Measured by the Shona Symptom Questionnaire.
Scores from 0-14, with a higher score indicating greater psychological distress.
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T2 (2 months post-baseline)
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Change in PrEP stigma (provider level)
Time Frame: Baseline, T3 (5 months post-baseline)
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Will be assessed via an adapted version of the Community PrEP-Related Stigma Scale.
Each item is measured on a 1-5 Likert Scale.
Scores range from 16-80, with higher scores indicating greater stigma.
PrEP stigma will be assessed at baseline and 5 months post-baseline to determine change in stigma after the intervention.
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Baseline, T3 (5 months post-baseline)
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Change in PrEP knowledge (provider level)
Time Frame: Baseline, T3 (5 months post-baseline)
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Will be assessed in a PrEP-Related Knowledge Scale adapted from the Fenway Institute.
Total scores may range from 0-8 with higher scores indicating greater PrEP knowledge.
PrEP knowledge will be assessed at baseline and 5 months post-baseline to determine change in knowledge after the intervention.
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Baseline, T3 (5 months post-baseline)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amelia M Stanton, PhD, Boston University
- Principal Investigator: Walter Mangezi, MD, University of Zimbabwe
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
Other Study ID Numbers
- 2023P003607
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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