An interventional study of mWACh-PrEP and Standard of Care in HIV Infections, Pregnancy Related and Adherence, Medication, sponsored by University of Washington. Recruiting at 4 sites in Kenya. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-16.
Sponsored by University of Washington · Not applicable, Interventional, and Prevention
In high HIV prevalence regions, women are at high risk for HIV during pregnancy and breastfeeding. To protect women and reach elimination of mother-to-child HIV transmission, the World Health Organization recommends offering oral tenofovir (TFV)-based pre-exposure prophylaxis (PrEP) to HIV-negative pregnant and postpartum women in high-burden settings. Although most pregnant Kenyan women with HIV risk factors accept PrEP when offered, >50% discontinue PrEP within 30 days of initiation and sub-optimal adherence is common. To date, no intervention studies to improve PrEP adherence include pregnant or postpartum women. The investigators adapted an SMS communication platform (mWACh) to send PrEP-tailored, theory-based SMS to facilitate adherence among pregnant women who initiate PrEP. In a non-randomized pilot, the investigators found that mWACh-PrEP recipients were more likely to persist with PrEP use and to self-report high adherence. The investigators propose a randomized trial to determine the effect of the mWACh-PrEP tool on PrEP adherence during pregnancy through the postpartum period. The investigators will also gather data on cost and delivery using the Proctor Implementation Outcomes Framework to expedite translation into routine practice. The overarching hypothesis is that mWACh-PrEP will improve PrEP adherence among mothers at-risk for HIV, be acceptable to patients and providers, and be cost-effective. The study will be executed via the following aims:
Aim 1- To determine the effect of the mWACh-PrEP tool on PrEP adherence during pregnancy through the postpartum period among women who initiate PrEP within ANC-PrEP. We will conduct a 2-arm randomized trial comparing mWACh-PrEP vs standard of care (SOC, i.e. in-clinic adherence counseling) among HIV-uninfected pregnant women with high HIV acquisition risk (defined by validated risk score) who initiate PrEP. The primary outcome will be adherence at 6 months postpartum (TFV hair levels >0.038 ng/mg; consistent with 7 pills/ week). Secondary outcomes will include sexually transmitted infection (STI) incidence, adherence cofactors, and prevention-effective adherence (time-varying alignment of adherence with risk behaviors). Exploratory outcomes will include HIV incidence and perinatal outcomes by arm. Hypothesis: mWACh-PrEP will increase PrEP adherence compared to SOC.
Aim 2- Evaluate barriers and facilitators of mWACh-PrEP implementation within routine ANC. Using the Proctor framework, we assess acceptability and feasibility by conducting interviews and focus-groups with ANC-PrEP users, providers, and health planners. Hypothesis: Indications for readiness of mWACh-PrEP will be identified.
Aim 3- Estimate the cost-effectiveness of implementing mWACh-PrEP within ANC-PrEP, per HIV infection and disability-adjusted life-year (DALY) averted. We use data from Aims 1 and conduct micro-costing and time-and-motion studies to estimate the cost of mWACh-PrEP from a payer perspective. The incremental cost-effectiveness ratio (ICER) per HIV infection and DALY averted compared to SOC will be calculated. Hypothesis: Incorporating data on PrEP and ANC outcomes with improve ICERs for mWACh-PrEP.
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Exclusion Criteria:
Behavioral: mWACh-PrEP · Other: Standard of Care
Other: Standard of Care
Participants randomized to mWACh-PrEP will be registered into the system, in addition to receipt of SOC services. Women registered into the mWACh-PrEP platform will indicate their preferences for message delivery including a preferred name for messaging, language (English or Kiswahili or Dholuo), and day of the week and time for SMS delivery. Once registered, women will receive weekly automated push messages on the day/time of their choice from enrollment through 6-months postpartum. All automated push messages will include participant nickname, clinic and nurse name, an educational message or actionable advice targeting PrEP adherence and continuation and/or maternal and child health (MCH) topics, and a question related to the content. SMS topics will include adherence encouragement, PrEP efficacy and safety, self-efficacy for prevention of HIV, support for potential PrEP side effects, behavioral skills (tips for remembering PrEP medications) and visit reminders.
All participants will receive SOC services for MCH and PrEP that will include health education, clinical assessments, laboratory safety monitoring, STI (syphilis, gonorrhea, and chlamydia) screening and treatment (including expedited partner treatment for
% of participants with detectable TFV levels in hair >0.038 ng/mg (PrEP adherence)
PrEP adherence will be measured with a binary endpoint (Yes/No) based on hair samples from 6-month postpartum visits. Detectable TFV levels in hair \>0.038 ng/mg (consistent with 7 doses/week) will be considered adherent. If a participant stopped PrEP use or exited the study before 6 months postpartum (ie had no hair sample collected), the participant will be considered non-adherent
Time frame: 6-months postpartum
% of participants with detectable TFV levels in hair >0.038 ng/mg (Sustained PrEP adherence)
Binary endpoint (Yes/No) of detectable TFV levels in hair \>0.038 ng/mg (consistent with 7 doses/week) at 9-months postpartum (3 months after cessation of mWACh messaging). Same definition of non-adherence as above.
Time frame: 9-months postpartum
% of participants with <90% PrEP adherence or discontinuation (Predictors of non-adherence)
Factors associated with poor adherence (outcomes of \<90% adherent on PrEP or discontinuation) will include demographics, relationship/partner characteristics, psychosocial factors, socioeconomic status, low health/HIV literacy, fear of disclosure
Time frame: 6-months postpartum
Incidence of STI diagnoses
Frequency of STI (syphilis, gonorrhea, chlamydia) detection at follow-up visits will be compared between randomization arms
Time frame: 6-months postpartum
Incidence of HIV acquisition
Frequency of HIV diagnosis at follow-up visits will be compared between randomization arms
Time frame: 6-months postpartum
% of participants who experience preterm birth, neonatal death, and infant growth faltering
Frequency of preterm birth, neonatal death, and infant growth faltering outcomes will be compared between randomization arms
Time frame: 6-months postpartum
% of participants who offer male partners expedited partner therapy (EPT)
Among women with STI diagnoses, frequency of offering male partners EPT will be compared between randomization arm
Time frame: 6-months postpartum
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