The TAP study
Not Applicable
- Conditions
- HIV/AIDS
- Registration Number
- PACTR201311000641402
- Lead Sponsor
- EDCTP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 230
Inclusion Criteria
1. ART-naïve individual (< 1 month prior ART) 12 years or older.
2. Been prescribed new antiretroviral therapy by a clinician at the clinic /study site.
3. At least one medication of the regimen must be in tablet formulation.
4. Willing to sign the patient informed consent if 18 years of age or above, or assent if 17 years old or below, to participate in the study. Parent or legal guardian must be willing to provide written consent for their child to participate in the study if 17 years or below.
Exclusion Criteria
1. Active disease which, in the opinion of the study staff, would preclude the informed consent process.
2. Participant or carer not in possession of a cellular telephone.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with a cumulative adherence by EAMD >95% at week 48 by arm.
- Secondary Outcome Measures
Name Time Method Proportion of patients with a viral load of <50 copies/ml at week 48; as well as proportion of patients who failed (consecutive VL >1000 copies/ml) by week 48. ;Comparison of cumulative EAMD adherence data and tablet count adherence data at weeks 16, 32 and 48. ;Proportion of patients still in care at 48 weeks (excluding those transferred to other ART sites); proportion with a treatment interruption of >72 hours. ;Mid-dosing efavirenz levels or trough nevirapine and lopinavir levels for discordant participants at weeks 16, 32 and 48.;Exploratory endpoint: relationship of PK results to adherence and to virological outcome at week 16, 32 and 48;Acceptability of EAMD device; impact of qualitative issues on adherence (alcohol, disclosure, mental health status, ART tolerability, life events).