HIV/AIDS Clinical Trial
— Mobile WAChxOfficial title:
Evaluation of Mhealth Strategies to Optimize Adherence and Efficacy of PMTCT/ART
Verified date | October 2022 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators are conducting a 3-arm randomized trial comparing the effects of unidirectional SMS (ie: "push" messaging to participant) vs. bidirectional SMS dialogue between participant and provider vs. control (no SMS) among HIV-infected Kenyan mothers in Kenyan PMTCT-ART for outcomes of ART adherence and retention in care.
Status | Completed |
Enrollment | 825 |
Est. completion date | February 28, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 14 Years and older |
Eligibility | Inclusion Criteria: - pregnant, HIV-infected, access to a mobile phone, remaining in study area for two years Exclusion Criteria: - enrolled in another research study |
Country | Name | City | State |
---|---|---|---|
Kenya | Ahero District Hospital | Ahero | |
Kenya | Bondo District Hospital | Bondo | |
Kenya | Mathare City Council Clinic | Nairobi | |
Kenya | Riruta Health Centre | Nairobi | |
Kenya | Rachuonyo sub-County Hospital | Oyugis | |
Kenya | Siaya County Referral Hospital | Siaya |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Kenyatta National Hospital, University of Nairobi |
Kenya,
Drake AL, Unger JA, Ronen K, Matemo D, Perrier T, DeRenzi B, Richardson BA, Kinuthia J, John-Stewart G. Evaluation of mHealth strategies to optimize adherence and efficacy of Option B+ prevention of mother-to-child HIV transmission: Rationale, design and methods of a 3-armed randomized controlled trial. Contemp Clin Trials. 2017 Jun;57:44-50. doi: 10.1016/j.cct.2017.03.007. Epub 2017 Mar 14. — View Citation
Fairbanks J, Beima-Sofie K, Akinyi P, Matemo D, Unger JA, Kinuthia J, O'Malley G, Drake AL, John-Stewart G, Ronen K. You Will Know That Despite Being HIV Positive You Are Not Alone: Qualitative Study to Inform Content of a Text Messaging Intervention to Improve Prevention of Mother-to-Child HIV Transmission. JMIR Mhealth Uhealth. 2018 Jul 19;6(7):e10671. doi: 10.2196/10671. — View Citation
Lewis K, Harrington EK, Matemo D, Drake AL, Ronen K, O'Malley G, Kinuthia J, John-Stewart G, Unger JA. Utilizing perspectives from HIV-infected women, male partners and healthcare providers to design family planning SMS in Kenya: a qualitative study. BMC Health Serv Res. 2019 Nov 21;19(1):870. doi: 10.1186/s12913-019-4708-7. — View Citation
Ronen K, Unger JA, Drake AL, Perrier T, Akinyi P, Osborn L, Matemo D, O'Malley G, Kinuthia J, John-Stewart G. SMS messaging to improve ART adherence: perspectives of pregnant HIV-infected women in Kenya on HIV-related message content. AIDS Care. 2018 Apr;30(4):500-505. doi: 10.1080/09540121.2017.1417971. Epub 2017 Dec 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maternal Virologic Failure | Prevalence of virologic failure (HIV RNA =1000 c/ml) after the first 4 months post-ART will be compared between study arms using Generalized Estimating Equations (GEE) with log-binomial link. | 2 years postpartum | |
Primary | Retention in Care | Timely clinic visit attendance during follow-up from enrollment in pregnancy to 12 and 24 months postpartum will be compared between study arms using GEE with log-binomial link. | Assessed at 24 months postpartum | |
Primary | Loss to Follow-up | The proportions of women lost to follow-up at 12 and 24 months postpartum will be compared between study arms by log-binomial regression. | Assessed at 24 months postpartum | |
Primary | Infant HIV-free Survival | Incidence of infant HIV acquisition or death (events per person-time of follow-up) will be compared between study arms using Cox proportional hazards regression. | 2 years postpartum | |
Secondary | Maternal ART Adherence | ART adherence, defined as the proportion of days "covered" by ART between pharmacy refills, will be dichotomized and compared between arms using GEE with log-binomial link. | 2 years postpartum | |
Secondary | Maternal ART Resistance | Incidence of drug resistance on ART will be compared between study arms using Cox proportional hazards regression. | 2 years postpartum | |
Secondary | Maternal Perceptions of Intervention and Care Received | Qualitative interviews at exit | 2 years postpartum |
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