Mobile Phone Messaging to Improve Reproductive Health for Women Living With HIV in Kenya (Mobile WACh Empower)
Primary Purpose
Hiv, Contraception, Fertility Issues
Status
Recruiting
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Digital counseling plus interactive two-way SMS dialogue
Sponsored by
About this trial
This is an interventional prevention trial for Hiv focused on measuring mHealth, HIV, conception, counseling, fertility, family planning, SMS, Kenya
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
Sites / Locations
- Bondo sub-County HospitalRecruiting
- Kisumu District General HospitalRecruiting
- Lumumba sub-County HospitalRecruiting
- Dandora 2 Health CenterRecruiting
- Kangemi Health CentreRecruiting
- Kenyatta National HospitalRecruiting
- Mathare North Health CenterRecruiting
- Riruta Health CenterRecruiting
- Rachuonyo DistrictRecruiting
- Siaya District HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Digital counseling plus interactive two-way SMS dialogue
Control
Arm Description
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.
Control receiving standard of care.
Outcomes
Primary Outcome Measures
Contraceptive discontinuation
Proportion not using contraception among women who initiated or continued contraception to prevent pregnancy
Secondary Outcome Measures
Uptake of dual methods of contraception
Proportion who use condoms plus another modern method of contraception
Unmet need for contraception
Proportion with a desire for pregnancy but not using contraception
Full Information
NCT ID
NCT05285670
First Posted
February 18, 2022
Last Updated
October 9, 2023
Sponsor
University of Washington
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT05285670
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv, Contraception, Fertility Issues
Keywords
mHealth, HIV, conception, counseling, fertility, family planning, SMS, Kenya
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
3300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Digital counseling plus interactive two-way SMS dialogue
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control receiving standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Digital counseling plus interactive two-way SMS dialogue
Intervention Description
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.
Primary Outcome Measure Information:
Title
Contraceptive discontinuation
Description
Proportion not using contraception among women who initiated or continued contraception to prevent pregnancy
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Uptake of dual methods of contraception
Description
Proportion who use condoms plus another modern method of contraception
Time Frame
2 years
Title
Unmet need for contraception
Description
Proportion with a desire for pregnancy but not using contraception
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Viral load suppression at conception
Description
Proportion with viral load <100 copies/mL among women planning to become pregnant or become pregnant
Time Frame
Up to 2 years
Title
Unintended pregnancy
Description
Proportion of women who become pregnant among women not intending pregnancy (excludes ambivalence)
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alison Drake, PHD
Phone
206 543-5847
Email
adrake2@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Drake, PHD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bondo sub-County Hospital
City
Bondo
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBChB
Phone
2540722799052
Email
kinuthia@uw.edu
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MbChb
Facility Name
Kisumu District General Hospital
City
Kisumu
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBCHB
Phone
2540722799052
Email
kinuthia@uw.edu
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBCHB
Facility Name
Lumumba sub-County Hospital
City
Kisumu
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBChB
Phone
2540722799052
Email
kinuthia@uw.edu
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBChB
Facility Name
Dandora 2 Health Center
City
Nairobi
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBCHB
Phone
2540722799052
Email
kinuthia@uw.edu
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBCHB
Facility Name
Kangemi Health Centre
City
Nairobi
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBCHB
Phone
2540722799052
Email
kinuthia@uw.edu
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBCHB
Facility Name
Kenyatta National Hospital
City
Nairobi
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBCHB
Phone
2540722799052
Email
kinuthia@uw.edu
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBCHB
Facility Name
Mathare North Health Center
City
Nairobi
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBCHB
Phone
2540722799052
Email
kinuthia@uw.edu
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBCHB
Facility Name
Riruta Health Center
City
Nairobi
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBCHB
Phone
2540722799052
Email
kinuthia@uw.edu
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBCHB
Facility Name
Rachuonyo District
City
Oyugis
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBCHB
Phone
2540722799052
Email
kinuthia@uw.edu
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBCHB
Facility Name
Siaya District Hospital
City
Siaya
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBCHB
Phone
2540722799052
Email
kinuthia@uw.edu
First Name & Middle Initial & Last Name & Degree
John Kinuthia, MBCHB
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Mobile Phone Messaging to Improve Reproductive Health for Women Living With HIV in Kenya (Mobile WACh Empower)
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