Health Trials

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

ConditionsHIV InfectionsPregnancy RelatedDepression, Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-55
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant

Presenting at the Chitungwiza Central Hospital ANC

Aged 15+

Willing to provide informed consent or assent

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • TENDAI4PrEP

    Behavioral

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

  • Enhanced treatment as usual

    Other intervention

    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.

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: TENDAI4PrEPExperimental treatment 1 intervention
Group B: Enhanced Treatment as Usual (ETAU)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
T3 (5 months post-baseline)
2

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.

Time frame
T3 (5 months post-baseline)
3

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.

Time frame
T3 (5 months post-baseline)
4

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.

Time frame
T3 (5 months post-baseline)

Secondary outcomes

1

Self-reported PrEP adherence (patient level)

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.

Time frame
T2 (2 months post-baseline)
2

Psychological distress (patient level)

Measured by the Shona Symptom Questionnaire. Scores from 0-14, with a higher score indicating greater psychological distress.

Time frame
T2 (2 months post-baseline)
3

PrEP persistence (patient level)

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.

Time frame
T3 (5 months post-baseline)
4

Change in PrEP knowledge (provider level)

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.

Time frame
Baseline, T3 (5 months post-baseline)

Other outcomes

Sponsors and contacts

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Massachusetts General Hospital

Lead sponsor

University of Zimbabwe

Collaborator

Boston University

Collaborator

Source ClinicalTrials.gov
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