SMS support to improve PrEP adherence for pregnant women
mWACh-PrEP: A SMS-based Support Intervention to Enhance PrEP Adherence During Pregnancy and Breastfeeding
This study tests whether sending supportive text messages can help pregnant women stay on their HIV prevention medication, PrEP, during pregnancy and breastfeeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Washington Academic / other |
| Locations | 4 sites (Kisumu and 3 other locations) |
| Trial ID | NCT04472884 on ClinicalTrials.gov |
What this trial studies
This intervention aims to enhance adherence to pre-exposure prophylaxis (PrEP) among HIV-negative pregnant women in high-prevalence regions. The study utilizes an SMS-based communication platform, mWACh, to deliver tailored messages that encourage adherence to PrEP during pregnancy and breastfeeding. By targeting women who have initiated PrEP, the study seeks to address the high discontinuation rates observed in this population. The effectiveness of this approach will be evaluated through a randomized trial comparing the SMS intervention to standard care.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older, between 24-32 weeks of gestation, who are HIV negative and have a high risk score for HIV.
Not a fit: Patients who do not plan to remain in the study area for at least one year or lack access to mobile phones may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve PrEP adherence among pregnant women, reducing their risk of HIV and preventing mother-to-child transmission.
How similar studies have performed: Previous pilot studies have shown promising results with SMS interventions for improving PrEP adherence, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women presenting for routine antenatal care (ANC) who are: * ≥18 years old * 24-32 weeks gestation * No documented tuberculosis infection * HIV negative (based on ANC HIV testing) * Plan to reside in area for at least one year postpartum * Plan to receive antenatal, postnatal, and infant care at study facility * Initiated PrEP during routine ANC * Have an HIV risk score \>6 (based on Pintye et al 2017). Exclusion Criteria: * Do not plan to remain in the study site catchment area for at least 1 year * Do not have mobile phones.
Where this trial is running
Kisumu and 3 other locations
- Kisumu County Referral Hospital — Kisumu, Kenya (Recruiting)
- Lumumba Sub County Hospital — Kisumu, Kenya (Recruiting)
- Migosi Sub County Hospital — Kisumu, Kenya (Recruiting)
- Yala Sub County Hospital — Siaya, Kenya (Recruiting)
Study contacts
- Principal investigator: Jillian Pintye, RN, MPH, PhD — University of Washington
- Study coordinator: Jillian Pintye, RN, MPH, PhD
- Email: jpintye@uw.edu
- Phone: (206) 543-8736
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.