mWACh-PrEP: A SMS-based Support Intervention to Enhance PrEP Adherence During Pregnancy and Breastfeeding

NCT ID: NCT04472884

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-14
• Study Completion Date: 2025-06-30

Brief Summary

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.

Conditions

HIV Infections; Pregnancy Related; Adherence, Medication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

mWACh-PrEP

Group Type: EXPERIMENTAL

mWACh-PrEP

Intervention Type: BEHAVIORAL

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.

Standard of Care

Intervention Type: OTHER

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

Standard of Care

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

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

Interventions

mWACh-PrEP

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.

Intervention Type: BEHAVIORAL

Standard of Care

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kenyatta National Hospital

OTHER_GOV

Sponsor Role: collaborator

Jomo Kenyatta University of Agriculture and Technology

OTHER

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jillian Pintye

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jillian Pintye, RN, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Kisumu County Referral Hospital

Kisumu, , Kenya

Site Status: RECRUITING

Lumumba Sub County Hospital

Kisumu, , Kenya

Site Status: RECRUITING

Migosi Sub County Hospital

Kisumu, , Kenya

Site Status: RECRUITING

Yala Sub County Hospital

Siaya, , Kenya

Site Status: RECRUITING

Countries

Kenya

Central Contacts

Jillian Pintye, RN, MPH, PhD

Role: CONTACT

jpintye@uw.edu

(206) 543-8736

Facility Contacts

Felix Abuna

Role: primary

Felix Abuna

Role: primary

Felix Abuna

Role: primary

Felix Abuna

Role: primary

References

Mogaka JN, Otieno FA, Akim E, Beima-Sofie K, Dettinger J, Gomez L, Marwa M, Odhiambo B, Ngure K, Ronen K, Sharma M, John-Stewart G, Richardson B, Stern J, Unger J, Udren J, Watoyi S, Pintye J, Kinuthia J. 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. JMIR Res Protoc. 2023 Jan 30;12:e41170. doi: 10.2196/41170.

Reference Type: DERIVED

PMID: 36716092 (View on PubMed)

Other Identifiers

1R01NR019220-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00010797

Identifier Type: -

Identifier Source: org_study_id