Effect of a customized digital adherence tool on retention in care among breastfeeding women living with HIV and adherence to antiretroviral treatment among children and adolescents living with HIV in Northern zone Tanzania.

Not Applicable

• Conditions: HIV/AIDS

• Registration Number: PACTR202301844164954
• Lead Sponsor: KILIMANJARO CLINICAL RESEARCH INSTITUTE KCRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

1.Mother/child/adolescent being HIV-positive
2.The infant of the mother being HIV exposed and aged less than 2 weeks
3.Attending Care and Treatment Centres (CTC) or postnatal clinics in Kilimanjaro and Arusha
4.Age of mother between 15-49 years, age of children living with HIV 0-14 years and adolescents living with HIV 15-19 years
5.Mother, caregiver/parents, and adolescents willing to use RTMM and/or receive SMS (participant will be provided with a phone if needed)
6.Mother, caregiver/parent, and adolescents able to read and understand SMS
7.Mother, caregiver/parent, and adolescents aged 18-19 able to understand and willing to sign informed consent
8.Adolescents aged 15-17 able and willing to sign informed assent.

Exclusion Criteria

1.Admission to hospital at study-entry
2.Participation in other trials related to adherence and retention into care
3.Previous participation in digital health research
4.Participation in the formative stage

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Proportion of breastfeeding women retained in care at 18 months. <br>2. Proportion of children and adolescents with adherence of 95% over 12 months of follow up.

Secondary Outcome Measures

Name	Time	Method
1.Breastfeeding women<br>a)Percentage of infants found to be HIV positive in 24 months post-partum between those whose mothers use DAT and those in standard care<br>b)Percentage of participants found to be virologically suppressed at month 12 and 24 between those who use DAT and those in standard care<br><br>2.Children and adolescents<br>a)Percentage of participants found to be virologically suppressed at month 12 between those who use DAT and those in standard care<br>3.All groups<br>a)Quality of life between those use DAT and those in standard care<br>b)To investigate whether standardized questionnaires for stigmatization, depression, social support and quality of life are context-specific<br>c)Feasibility and acceptability of the digital adherence tool<br>d)Cost effectiveness of the digital adherence tool compare to the standard of care <br>