HIV InfectionsNCT04472884
mWACh-PrEP: A SMS-based Support Intervention to Enhance PrEP Adherence During Pregnancy and Breastfeeding
A study testing mWACh-PrEP in people with HIV Infections and Pregnancy Related, run by University of Washington at 4 sites in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Pregnancy Related, Adherence, Medication
- What is being tested?
- mWACh-PrEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 4 sitesKenya
- Study dates
- 14 Feb 2022to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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).
Who cannot join
- Do not plan to remain in the study site catchment area for at least 1 year
- Do not have mobile phones.
Trial locations and contacts
4 sites in 1 country.
Kenya4 sites, 4 recruiting
- Recruiting
Kisumu County Referral Hospital
Kisumu
Felix Abuna
- Recruiting
Lumumba Sub County Hospital
Kisumu
Felix Abuna
- Recruiting
Migosi Sub County Hospital
Kisumu
Felix Abuna
- Recruiting
Yala Sub County Hospital
Siaya
Felix Abuna
About this study
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.
Read more
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
- Being tested
- mWACh-PrEP, Standard of Care
- Keywords
- pre-exposure prophylaxis, HIV prevention, PrEP
- Medical subject headings
- HIV Infections, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mWACh-PrEPBehavioural
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 CareOther
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
| Study group | Role | What they receive |
|---|---|---|
| mWACh-PrEP | Experimental | Not described Receives: Behavioral: mWACh-PrEP; Other: Standard of Care |
| Standard of Care | Other | Not described Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
% 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
Measured: 6-months postpartum
Secondary outcomes (3)
% 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.
Measured: 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
Measured: 6-months postpartum
Incidence of STI diagnoses
Frequency of STI (syphilis, gonorrhea, chlamydia) detection at follow-up visits will be compared between randomization arms
Measured: 6-months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start14 Feb 2022
- Primary completionMar 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Kenyatta National Hospital, Jomo Kenyatta University of Agriculture and Technology, National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Jillian Pintye, University of Washington
- Investigators
- Jillian Pintye, RN, MPH, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472884
- Sponsor's protocol ID
- STUDY00010797
- Other IDs
- 1R01NR019220-01A1
- Status last verified
- May 2023
- First submitted
- 10 Jul 2020
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Concepcion T, Watoyi S, Flaherty BP, Abuna F, Akim E, Gomez L, John-Stewart G, Nzove EM, Ngumbau N, Mogaka JN, Odhiambo BO, Wagner AD, Kinuthia J, Pintye J. Long-Acting HIV Pre-exposure Prophylaxis Preferences Through Pregnancy and the Postpartum Period Among Women in Kenya: A Latent Transition Analysis. AIDS Behav. 2026 Jun 29. doi: 10.1007/s10461-026-05197-0. Online ahead of print.
PubMed 42371241Mogaka 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.
PubMed 36716092
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mWACh-PrEP: A SMS-based Support Intervention to Enhance PrEP Adherence During Pregnancy and Breastfeeding
- ClinicalTrials.gov ID
- NCT04472884
- Acronym / sponsor ID
- STUDY00010797
- Conditions
- HIV Infections, Pregnancy Related, Adherence, Medication
- Keywords
- pre-exposure prophylaxis, HIV prevention, PrEP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Kenyatta National Hospital, Jomo Kenyatta University of Agriculture and Technology, National Institute of Nursing Research (NINR)
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mWACh-PrEP | Experimental | Behavioral: mWACh-PrEP, Other: Standard of Care |
| Standard of Care | Other | Other: Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (2 listed)
- Do not plan to remain in the study site catchment area for at least 1 year
- Do not have mobile phones.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mWACh-PrEPParticipants 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. | Behavioural | mWACh-PrEP |
| Standard of CareAll 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 | Other | Standard of Care, mWACh-PrEP |
Primary outcome
% of participants with detectable TFV levels in hair >0.038 ng/mg (PrEP adherence)
Time frame: 6-months postpartum
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
3 secondary outcomes
% of participants with detectable TFV levels in hair >0.038 ng/mg (Sustained PrEP adherence)
Time frame: 9-months postpartum
% of participants with <90% PrEP adherence or discontinuation (Predictors of non-adherence)
Time frame: 6-months postpartum
Incidence of STI diagnoses
Time frame: 6-months postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Derived from this study: PubMed 42371241Concepcion T, Watoyi S, Flaherty BP, Abuna F, Akim E, Gomez L, John-Stewart G, Nzove EM, Ngumbau N, Mogaka JN, Odhiambo BO, Wagner AD, Kinuthia J, Pintye J. Long-Acting HIV Pre-exposure Prophylaxis Preferences Through Pregnancy and the Postpartum Period Among Women in Kenya: A Latent Transition Analysis. AIDS Behav. 2026 Jun 29. doi: 10.1007/s10461-026-05197-0. Online ahead of print.
- Derived from this study: PubMed 36716092Mogaka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jillian Pintye, RN, MPH, PhD principal investigator
University of Washington
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mWACh-PrEP in people with HIV Infections and Pregnancy Related, run by University of Washington at 4 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jillian Pintye, RN, MPH, PhD ((206) 543-8736, jpintye@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of participants with detectable TFV levels in hair >0.038 ng/mg (PrEP adherence) (time frame: 6-months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04472884, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.