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

NCT ID: NCT05285670

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2026-06-30

Brief 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. 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.

Conditions

Hiv; Contraception; Fertility Issues

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Digital counseling plus interactive two-way SMS dialogue

Intervention Type: BEHAVIORAL

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.

Control

Control receiving standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Alison Drake

Associate Professor, SPH: Global Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alison Drake, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Bondo sub-County Hospital

Bondo, , Kenya

Site Status: RECRUITING

Kisumu District General Hospital

Kisumu, , Kenya

Site Status: RECRUITING

Lumumba sub-County Hospital

Kisumu, , Kenya

Site Status: RECRUITING

Dandora 2 Health Center

Nairobi, , Kenya

Site Status: RECRUITING

Kangemi Health Centre

Nairobi, , Kenya

Site Status: RECRUITING

Kenyatta National Hospital

Nairobi, , Kenya

Site Status: RECRUITING

Mathare North Health Center

Nairobi, , Kenya

Site Status: RECRUITING

Riruta Health Center

Nairobi, , Kenya

Site Status: RECRUITING

Rachuonyo District

Oyugis, , Kenya

Site Status: RECRUITING

Siaya District Hospital

Siaya, , Kenya

Site Status: RECRUITING

Countries

Kenya

Central Contacts

Alison Drake, PHD

Role: CONTACT

adrake2@uw.edu

206 543-5847

Facility Contacts

John Kinuthia, MBChB

Role: primary

kinuthia@uw.edu

2540722799052

John Kinuthia, MBCHB

Role: primary

kinuthia@uw.edu

2540722799052

John Kinuthia, MBChB

Role: primary

kinuthia@uw.edu

2540722799052

John Kinuthia, MBCHB

Role: primary

kinuthia@uw.edu

2540722799052

John Kinuthia, MBCHB

Role: primary

kinuthia@uw.edu

2540722799052

John Kinuthia, MBCHB

Role: primary

kinuthia@uw.edu

2540722799052

John Kinuthia, MBCHB

Role: primary

kinuthia@uw.edu

2540722799052

John Kinuthia, MBCHB

Role: primary

kinuthia@uw.edu

2540722799052

John Kinuthia, MBCHB

Role: primary

kinuthia@uw.edu

2540722799052

John Kinuthia, MBCHB

Role: primary

kinuthia@uw.edu

2540722799052

References

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.

Reference Type: BACKGROUND

PMID: 38557692 (View on PubMed)

Other Identifiers

R01HD104551

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00013136

Identifier Type: -

Identifier Source: org_study_id