Clinical trial NCT05285670: Mobile Phone Messaging to Improve Reproductive Health for Women Living With HIV in Kenya (Mobile WACh Empower)
Official title: Mobile Solutions to Empower Reproductive Life Planning for Women Living With HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Contraception
Fertility Issues
Keywords: mHealth
HIV
conception
counseling
fertility
family planning
SMS
Kenya
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-03-17
Enrollment: 3300
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Contraceptive discontinuation
timeFrame: 2 years
Secondary outcomes:
measure: Uptake of dual methods of contraception
timeFrame: 2 years
measure: Unmet need for contraception
timeFrame: 2 years
Other outcomes:
measure: Viral load suppression at conception
timeFrame: Up to 2 years
measure: Unintended pregnancy
timeFrame: 2 years
Locations:
city: Bondo
country: Kenya
facility: Bondo sub-County Hospital
city: Kisumu
country: Kenya
facility: Kisumu District General Hospital
city: Kisumu
country: Kenya
facility: Lumumba sub-County Hospital
city: Nairobi
country: Kenya
facility: Dandora 2 Health Center
city: Nairobi
country: Kenya
facility: Kangemi Health Centre
city: Nairobi
country: Kenya
facility: Kenyatta National Hospital
city: Nairobi
country: Kenya
facility: Mathare North Health Center
city: Nairobi
country: Kenya
facility: Riruta Health Center
city: Oyugis
country: Kenya
facility: Rachuonyo District
city: Siaya
country: Kenya
facility: Siaya District Hospital
Study officials:
affiliation: University of Washington
name: Alison Drake, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.