HIV Infections / Depression, Anxiety / Enhanced treatment as usual · Interventional Study

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

ClinicalTrials.gov · September 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for a recruiting interventional study adapting the TENDAI problem-solving intervention to improve PrEP uptake and adherence among pregnant persons in Zimbabwe. The study is in the feasibility and acceptability phase, with no results yet reported. No clinical outcome data are available to inform practice decisions.

What was studied

Interventional, Randomized, Parallel, Single masking, Prevention purpose. HIV Infections, Pregnancy Related, Depression, Anxiety; age from 15 Years; to 55 Years. Intervention: TENDAI4PrEP. Compared with: Enhanced Treatment as Usual (ETAU) — Active Comparator. n = 165. 1 site: Zimbabwe.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a recruiting interventional study testing feasibility and acceptability of a behavioral intervention for PrEP adherence in pregnant women; no results are yet reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Feasibility (patient level) (assessed at T3 (within 5 months post-baseline)); Acceptability (patient level) (assessed at T3 (within 5 months post-baseline)); Feasibility (provider level) (assessed at T3 (within 5 months post-baseline)); Acceptability (provider level) (assessed at T3 (within 5 months post-baseline))

DesignInterventional, Randomized, Parallel, Single masking, Prevention purpose

PopulationHIV Infections, Pregnancy Related, Depression, Anxiety; age from 15 Years; to 55 Years

Sample size165

InterventionTENDAI4PrEP

ComparatorEnhanced Treatment as Usual (ETAU) — Active Comparator

Setting1 site: Zimbabwe

Reported figures

Quoted from the source exactly as published.

Estimated enrollment165

Primary outcome measure 1Feasibility (patient level) at T3 (within 5 months post-baseline)

Primary outcome measure 2Acceptability (patient level) at T3 (within 5 months post-baseline)

Primary outcome measure 3Feasibility (provider level) at T3 (within 5 months post-baseline)

Primary outcome measure 4Acceptability (provider level) at T3 (within 5 months post-baseline)

Caveats

This is a registry record only; no results are posted or available for analysis.
Study phase not specified; feasibility and acceptability are surrogate endpoints, not clinical efficacy or effectiveness measures.
Blinding status, allocation method, and follow-up duration beyond T3 are not reported.
No interim or final efficacy data are available; the record states that if feasibility and acceptability are demonstrated, the intervention will advance to large-scale effectiveness testing.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Interventional with behavioral and comparator arms; phase not specified by sponsor.

Directness

strong

Directly addresses PrEP uptake and persistence in pregnant persons in Zimbabwe.

Consistency

insufficient

No results reported; consistency with prior evidence cannot be assessed.

Risk of bias

insufficient

Registry record does not report blinding, allocation concealment, or outcome assessment methods.

Sample adequacy

moderate

Estimated 165 participants; adequate for feasibility and acceptability assessment.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06226155). This is a study registration, not published results. Lead sponsor: Massachusetts General Hospital. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 165 participants (ESTIMATED). Conditions: HIV Infections, Pregnancy Related, Depression, Anxiety. Interventions: BEHAVIORAL: TENDAI4PrEP; OTHER: Enhanced treatment as usual. Primary outcome measures: Feasibility (patient level) , T3 (within 5 months post-baseline); Acceptability (patient level) , T3 (within 5 months post-baseline); Feasibility (provider level) , T3 (within 5 months post-baseline); Acceptability (provider level) , T3 (within 5 months post-baseline). 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

HIV InfectionsNCT06226155Depression, AnxietyEnhanced treatment as usualTENDAI4PrEPMassachusetts General HospitalPregnancy Related