A Text Messaging–Based Support Intervention to Enhance Pre-exposure Prophylaxis for HIV Prevention Adherence During Pregnancy and Breastfeeding: Protocol for a Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: Cisgender women in Kenya are at elevated risk of HIV acquisition during pregnancy and post partum. Acute HIV infection during pregnancy and breastfeeding accounts for approximately one-third of all vertical HIV transmissions. The World Health Organization recommends offering oral tenofovir-based pre-exposure prophylaxis (PrEP) to pregnant and postpartum women who are HIV negative but at substantial and ongoing risk for HIV acquisition. PrEP delivery for pregnant and postpartum women is expanding within routine maternal child health clinics in Kenya. However, approximately half of pregnant women discontinue PrEP within 30 days of initiation. Therefore, it is crucial to develop PrEP adherence strategies that enhance support for adherence when peripartum events and health issues pose challenges to sustaining PrEP adherence. OBJECTIVE: We are conducting a randomized controlled trial to determine the effect of a bidirectional communication platform named Mobile Solutions for Women's and Children's Health (mWACh), which utilizes two-way SMS text messaging between patients and remote nurses to support PrEP adherence and address maternal health concerns in real time during the peripartum period. METHODS: The mWACh-PrEP study is a randomized trial designed to support PrEP adherence during the peripartum period by comparing mWACh-PrEP to the standard of care (ie, in-clinic adherence counseling) among women who are HIV negative and initiating PrEP. Purposive sampling was used to select 5 facilities offering PrEP in antenatal clinics in Kisumu and Siaya Counties, and block randomization will be used to divide participants into groups. Participants in the intervention arm will receive a customized messaging curriculum via SMS text messages targeted toward their particular perinatal stage. The primary outcome, PrEP adherence at 6 months post partum, will be evaluated using a log-binomial regression model, adjusting for imbalanced baseline characteristics. Based on a previous study of directly observed dosing conditions, we will use a hair tenofovir concentration cutoff of 0.038 ng/mg (corresponding to 7 doses/week) as the primary adherence outcome measured at 6 months post partum (binary outcome). Qualitative interviews and cost-effective analyses will be conducted to understand the feasibility, acceptability, and economic impact of the intervention. RESULTS: Enrollment began in March 2022 and is projected to continue until July 2023, with follow-up through March 2024. The study results are expected to be reported in 2025. CONCLUSIONS: This trial will provide insights into using mobile health to enhance PrEP adherence among pregnant and postpartum mothers. Additionally, the findings will have implications for the use of mobile health technology to improve adherence to other daily medications during the peripartum period. TRIAL REGISTRATION: ClinicalTrials.gov NCT04472884; https://clinicaltrials.gov/ct2/show/NCT04472884. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41170.
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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 | 0.025 | 0.023 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.013 | 0.005 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.004 | 0.003 |
| Scholarly communication | 0.005 | 0.004 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.007 | 0.009 |
| Insufficient payload (model declined to judge) | 0.089 | 0.010 |
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".