Mobile Phone Messaging to Improve Reproductive Health for Women Living With HIV in Kenya (Mobile WACh Empower)

February 3, 2026 updated by: Alison Drake, University of Washington

Mobile Solutions to Empower Reproductive Life Planning for Women Living With HIV

Use of a mobile health (mHealth) intervention to provide reproductive life counseling to women living with HIV may improve delivery of integrated reproductive health/HIV services and prevent adverse reproductive health outcomes. The proposed study will evaluate SMS platform and reproductive health counseling intervention in a cluster randomized controlled trial among women receiving routine HIV care, and plan for future implementation with qualitative and health economic analyses.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Meeting reproductive health needs of women living with HIV (WLWH) is essential to help women prevent unintended pregnancies, safely conceive, and eliminate mother-to-child HIV transmission (MTCT). Reproductive life planning is complex for WLWH, who are faced with making decisions about antiretroviral treatment selections and potential for drug interactions with contraceptive methods, planning for safe conception, and planning to prevent sexually transmitted infections. While family planning (FP) use is high among WLWH, discontinuation of FP is common among women who desire pregnancy prevention, and is an important driver of unmet need for FP and subsequent risk of unintended pregnancy and adverse maternal and child health outcomes. Many programs in sub-Saharan Africa integrate FP service delivery into routine HIV care, but HIV care providers face challenges with implementing these models of care. HIV care providers may be ill equipped to ensure WLWH receive high-quality, rights' based reproductive health counseling and services due to lack time, training, resources, and skills. Prior studies on integrating FP services into HIV care consistently cite implementation challenges. Mobile health technology may provide a low cost solution to augment counseling services, strengthen health care systems, and alleviate demands on HIV providers. The investigators hypothesize that providing comprehensive counseling and two-way SMS communication, will 1) improve delivery of integrated HIV and reproductive health care services, 2) reduce contraceptive discontinuation rates, 3) be acceptable and feasible to implement, and 4) be cost-effective and contribute to prevention MTCT efforts. The investigators will adapt a unique two-way SMS platform (Mobile WACh) that combines automated bulk SMS messaging and dialogue with a health care provider for a new population, new environment, and new outcomes for long-term impact. The Mobile WACh platform will be customized to provide continuous reproductive life planning counseling for WLWH. The investigators will test the combined intervention in a cluster randomized controlled trial among women receiving HIV care at 10 facilities in Kenya (330 per facility). The investigators propose to evaluate the effect of the counseling and SMS communication intervention, Mobile WACh Empower, on reproductive health outcomes. In Aim 1, the investigators will determine the effect of the Mobile WACh Empower intervention on FP discontinuation, dual method use, and unmet need for FP over 2 years. In Aim 2, the investigators will evaluate acceptability, feasibility, and scalability of implementing Mobile WACh Empower under real-world settings, from both WLWH and provider perspectives in focus group discussions. In Aim 3, the investigators will construct a mathematical model to measure health and economic impacts of Mobile WACh Empower, including cost-effectiveness of the intervention per pregnancy and MTCT averted. This trial will evaluate a novel intervention to address a crucial gap in provision of integrated reproductive health and HIV care, and has the potential to make a significant contribution to global goals of universal access to FP and elimination of MTCT.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3310

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Alison Drake, PHD
  • Phone Number: 206 543-5847
  • Email: adrake2@uw.edu

Study Locations

  • Kenya
      • Bondo, Kenya
        • Bondo sub-County Hospital
      • Kisumu, Kenya
        • Lumumba sub-County Hospital
      • Kisumu, Kenya
        • Kisumu District General Hospital
      • Nairobi, Kenya
        • Kenyatta National Hospital
      • Nairobi, Kenya
        • Riruta Health Center
      • Nairobi, Kenya
        • Dandora 2 Health Center
      • Nairobi, Kenya
        • Kangemi Health Centre
      • Nairobi, Kenya
        • Mathare North Health Center
      • Oyugis, Kenya
        • Rachuonyo District
      • Siaya, Kenya
        • Siaya District Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • HIV-infected
  • Receiving HIV care at study site
  • Reproductive age (18-45; 14-17 if emancipated minors)
  • Daily access to mobile phone (own phone or shared)
  • Plan to receive HIV care at enrollment facility for 2 years
  • Speak English, Kiswahili, or Luo
  • Literate or comfortable with someone reading study SMS

Exclusion Criteria:

  • Currently pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Digital counseling plus interactive two-way SMS dialogue
Participants will receive initial counseling on a tablet followed by automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.
Behavioral: Digital counseling plus interactive two-way SMS dialogue
We will utilize a digital counseling tool on a tablet to provide initial reproductive life planning counseling while waiting for an HIV care provider. We will then use Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women following enrollment and for up to 2 years. Women will receive automated theoretically grounded SMS messages targeting the appropriate reproductive health needs and will have the capability to respond and spontaneously message a nurse based at the clinic. . Automated SMS will be delivered at times and in languages based on patient preferences, weekly the first 3 months, every other week in months 4-12, and monthly during the last year of the trial. If there is a change in the reproductive health needs, more frequent messaging will be re-initiated at the same frequency as enrollment.
No Intervention: Control
Control receiving standard of care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Contraceptive discontinuation
Time Frame: 2 years
Proportion not using contraception among women who initiated or continued contraception to prevent pregnancy
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Uptake of dual methods of contraception
Time Frame: 2 years
Proportion who use condoms plus another modern method of contraception
2 years
Unmet need for contraception
Time Frame: 2 years
Proportion with a desire for pregnancy but not using contraception
2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Viral load suppression at conception
Time Frame: Up to 2 years
Proportion with viral load <100 copies/mL among women planning to become pregnant or become pregnant
Up to 2 years
Unintended pregnancy
Time Frame: 2 years
Proportion of women who become pregnant among women not intending pregnancy (excludes ambivalence)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alison Drake, PHD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00013136
  • R01HD104551 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data from Mobile WACh Empower will be available at end of the project by contacting the study team at the University of Washington. De-identified data and variables requested.

IPD Sharing Time Frame

At the end of the study, available for 5 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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