Supporting Oral and Long-Acting HIV Preexposure Prophylaxis Decision-Making Among Pregnant Women (MyChoice Intervention): Protocol for 2 Pilot Randomized Controlled Trials
Bibliographic record
Abstract
BACKGROUND: HIV preexposure prophylaxis (PrEP) has potential for preventing HIV during the perinatal period, but few strategies promote person-centered shared decision-making (SDM) about PrEP use in these contexts. The MyChoice study aims to evaluate the feasibility, acceptability, and appropriateness of an SDM approach to support pregnant and breastfeeding women in Lilongwe, Malawi, integrating PrEP into antenatal care to encourage consistent use. OBJECTIVE: Two pilot studies will assess the feasibility, acceptability, and appropriateness of an SDM intervention to support pregnant and breastfeeding women in making informed HIV prevention choices. The intervention will also explore the perspectives of participants, their male partners, and implementers. Each study compares the MyChoice intervention to standard-of-care PrEP counseling, with different HIV prevention method choices available. METHODS: We will conduct 2 pilot randomized trials to evaluate the MyChoice intervention, designed to support PrEP decision-making among pregnant women in Lilongwe. Both studies will compare the MyChoice intervention to standard-of-care PrEP counseling. Study 1 will include 100 participants who will be offered oral PrEP and condoms for 3 months. Study 2 will include 50 participants who will be offered oral PrEP or injectable long-acting cabotegravir and condoms for 2 months. The primary end points for MyChoice study 1 are intervention acceptability, intervention appropriateness, and intervention feasibility, whereas for MyChoice study 2 they are intervention acceptability and intervention appropriateness. The secondary end point for MyChoice study 1 is decisional conflict, and for MyChoice study 2, it is the feasibility of study procedures. Exploratory end points include PrEP uptake assessment and dried blood spot measurement of PrEP adherence for MyChoice study 1 and PrEP uptake assessment for MyChoice study 2. RESULTS: Data collection started on July 30, 2024, for study 1 and on February 10, 2025, for study 2. A total of 100 participants were enrolled in MyChoice study 1, and 50 participants were enrolled in MyChoice study 2. Study follow-up has been completed. Data analysis is expected to be completed by November 2025. CONCLUSIONS: The MyChoice pilot studies will provide critical evidence on a novel intervention for PrEP decision-making during pregnancy and breastfeeding. If feasible and acceptable, these results will form the basis for larger efficacy trials to promote PrEP uptake during pregnancy. TRIAL REGISTRATION: ClinicalTrials.gov NCT06394323; https://clinicaltrials.gov/study/NCT06394323 and ClinicalTrials.gov NCT06397690; https://www.clinicaltrials.gov/study/NCT06397690. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/76442.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.055 | 0.054 |
| Meta-epidemiology (narrow) | 0.007 | 0.004 |
| Meta-epidemiology (broad) | 0.011 | 0.008 |
| Bibliometrics | 0.004 | 0.005 |
| Science and technology studies | 0.005 | 0.004 |
| Scholarly communication | 0.006 | 0.004 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.008 | 0.011 |
| Insufficient payload (model declined to judge) | 0.096 | 0.013 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".