An Adaptive Strategy for Preventing and Treating Lapses of Retention in Adult HIV Care (AdaPT-R) in Nyanza, Kenya

• Register: ClinicalTrials.gov
• Last refreshed on: 22 March 2021
• Main ID: NCT02338739
• Date of registration: 11/12/2014
• Prospective Registration: Yes
• Primary sponsor: University of California, San Francisco
• Public title: An Adaptive Strategy for Preventing and Treating Lapses of Retention in Adult HIV Care (AdaPT-R) in Nyanza, Kenya AdaPT-R
• Scientific title: An Adaptive Strategy for Preventing and Treating Lapses of Retention in Adult HIV Care (AdaPT-R)
• Date of first enrolment: March 2015
• Target sample size: 1816
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02338739
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Kenya

Contacts

• Name: Elvin Geng, MD
• Affiliation: University of California, San Francisco

• Name: Maya Petersen, MD, PhD
• Affiliation: University of California, Berkeley

Key inclusion & exclusion criteria

Inclusion Criteria:

- HIV-infection

- 18 years old

- Planning to remain in the study area (Nyanza region) for the duration of the study,
capable of informed consent

- Newly initiating ART (within past 90 days)

- Access to a cell phone

- Ability to read or be read SMS messages

- And willingness to be contacted by clinic upon missed appointment.

Exclusion Criteria:

- Plans to move out of Nyanza region or acutely ill and requiring hospitalization.

- Hospitalized patients who later recover will be eligible for enrolment at the first
post-hospitalization clinic visit during which eligibility criteria are met.

- No access to a cell phone.

- Involvement in studies with the potential to influence retention behaviors.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Behavioral: SMS; Outreach if Failure

Behavioral: SMS; Navigator if Failure

Behavioral: SMS; Navigator if Failure; Stop SMS if Success

Behavioral: REC; Outreach if Failure

Behavioral: Voucher; Outreach if Failure; Stop Voucher if Success

Behavioral: Voucher; SMS+Voucher if Failure

Behavioral: SMS; Outreach if Failure; Stop SMS if Success

Behavioral: SMS; SMS+Voucher if Failure; Stop SMS if Success

Behavioral: Voucher; Navigator if Failure; Stop Voucher if Success

Behavioral: Voucher; SMS+Voucher if Failure; Stop Voucher if Success

Behavioral: SMS; SMS+Voucher if Failure

Behavioral: Voucher; Navigator if Failure

Behavioral: REC; Navigator if Failure

Behavioral: REC; SMS + Voucher if Failure

Behavioral: Voucher; Outreach if Failure

Primary Outcome(s)

Retention [Time Frame: Up to two years after enrollment]

Secondary Outcome(s)

Patient-reported barriers to engagement [Time Frame: At years one and two after study enrollment]

Time from second randomization to return to clinic after initial retention lapse [Time Frame: Up to two years after enrollment]

Fraction on-time pharmacy pick-ups for antiretroviral drugs [Time Frame: Two years after enrollment]

Retention [Time Frame: Two years after enrollment]

Alive with suppressed HIV RNA level (<400 copies/ml) [Time Frame: Two years after study enrollment]

Mean visit adherence (% visits made) [Time Frame: Two years after study enrollment]

Cost effectiveness [Time Frame: After two years of enrollment]

Secondary ID(s)

1R01MH104123-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of California, Berkeley

National Institute of Mental Health (NIMH)

Kenya Medical Research Institute

University of Washington