HivNCT05285670
Mobile Phone Messaging to Improve Reproductive Health for Women Living With HIV in Kenya (Mobile WACh Empower)
A study testing Digital counseling plus interactive two-way SMS dialogue in people with Hiv and Contraception, run by University of Washington at 10 sites in Kenya.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hiv, Contraception, Fertility Issues
- What is being tested?
- Digital counseling plus interactive two-way SMS dialogue
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,310 participants
- Where
- 10 sitesKenya
- Study dates
- 1 Dec 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Currently pregnant
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Kenya10 sites
Bondo sub-County Hospital
Bondo
Kisumu District General Hospital
Kisumu
Lumumba sub-County Hospital
Kisumu
Dandora 2 Health Center
Nairobi
Kangemi Health Centre
Nairobi
Kenyatta National Hospital
Nairobi
Mathare North Health Center
Nairobi
Riruta Health Center
Nairobi
Rachuonyo District
Oyugis
Siaya District Hospital
Siaya
About this study
Official title: 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.
Read the 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.
- Conditions
- Hiv, Contraception, Fertility Issues
- Being tested
- Digital counseling plus interactive two-way SMS dialogue
- Keywords
- mHealth, HIV, conception, counseling, fertility, family planning, SMS, Kenya
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital counseling plus interactive two-way SMS dialogueBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital counseling plus interactive two-way SMS dialogue | Experimental | 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. Receives: Behavioral: Digital counseling plus interactive two-way SMS dialogue |
| Control | No intervention | Control receiving standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraceptive discontinuation
Proportion not using contraception among women who initiated or continued contraception to prevent pregnancy
Measured: 2 years
Secondary outcomes (2)
Uptake of dual methods of contraception
Proportion who use condoms plus another modern method of contraception
Measured: 2 years
Unmet need for contraception
Proportion with a desire for pregnancy but not using contraception
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Dec 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies 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
- Model description
- Participants will be randomized to 1) A digital counseling tool plus interactive two-way SMS dialogue or 2) Control (no SMS) at the clinic level, using 1:1 allocation at the clinic level.
- Masking
- None (open label)
- Enrolment
- 3,310 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Alison Drake, University of Washington
- Investigators
- Alison Drake, PHD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285670
- Sponsor's protocol ID
- STUDY00013136
- Other IDs
- R01HD104551
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2022
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Ngumbau N, Unger JA, Wandika B, Atieno C, Beima-Sofie K, Dettinger J, Nzove E, Harrington EK, Karume AK, Osborn L, Sharma M, Richardson BA, Seth A, Udren J, Zanial N, Kinuthia J, Drake AL. Mobile solutions to Empower reproductive life planning for women living with HIV in Kenya (MWACh EMPOWER): Protocol for a cluster randomized controlled trial. PLoS One. 2024 Apr 1;19(4):e0300642. doi: 10.1371/journal.pone.0300642. eCollection 2024.
PubMed 38557692
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Solutions to Empower Reproductive Life Planning for Women Living With HIV
- ClinicalTrials.gov ID
- NCT05285670
- Acronym / sponsor ID
- STUDY00013136
- Conditions
- Hiv, Contraception, Fertility Issues
- Keywords
- mHealth, HIV, conception, counseling, fertility, family planning, SMS, Kenya
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,310 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 Mar 2022 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to 1) A digital counseling tool plus interactive two-way SMS dialogue or 2) Control (no SMS) at the clinic level, using 1:1 allocation at the clinic level.
| Arm | Type | Receives |
|---|---|---|
| Digital counseling plus interactive two-way SMS dialogue | Experimental | Behavioral: Digital counseling plus interactive two-way SMS dialogueParticipants 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. |
| Control | No intervention | –Control receiving standard of care. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Currently pregnant
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 |
|---|---|---|
| Digital counseling plus interactive two-way SMS dialogueWe 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. | Behavioural | Digital counseling plus interactive two-way SMS dialogue |
Primary outcome
Contraceptive discontinuation
Time frame: 2 years
Proportion not using contraception among women who initiated or continued contraception to prevent pregnancy
2 secondary outcomes
Uptake of dual methods of contraception
Time frame: 2 years
Unmet need for contraception
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 38557692Ngumbau N, Unger JA, Wandika B, Atieno C, Beima-Sofie K, Dettinger J, Nzove E, Harrington EK, Karume AK, Osborn L, Sharma M, Richardson BA, Seth A, Udren J, Zanial N, Kinuthia J, Drake AL. Mobile solutions to Empower reproductive life planning for women living with HIV in Kenya (MWACh EMPOWER): Protocol for a cluster randomized controlled trial. PLoS One. 2024 Apr 1;19(4):e0300642. doi: 10.1371/journal.pone.0300642. eCollection 2024.
- Individual participant dataSharing planned: Yes. 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.
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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.
Alison Drake, PHD principal investigator
University of Washington
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital counseling plus interactive two-way SMS dialogue in people with Hiv and Contraception, run by University of Washington at 10 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 7 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraceptive discontinuation (time frame: 2 years). 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 NCT05285670, which also lists 1 linked publication.
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 5 Feb 2026.