Skip to content

A5250: DURABILITY OF ADHERENCE IN SELF-MANAGEMENT OF HIV (DASH)

A5250: DURABILITY OF ADHERENCE IN SELF-MANAGEMENT OF HIV (DASH)

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-046-11
Enrollment
120
Registered
2011-08-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

IN STAGE 1, TWO FOCUS GROUPS WILL BE CONDUCTED IN EACH OF TWO LOCATIONS: UNIVERSITY OF CALIFORNIA, SAN DIEGO (UCSD) AND YRG CENTER OF AIDS RESEARCH & EDUCATION (YRG CARE), CHENNAI, INDIA. IN EACH LOCA

Sponsors

El Instituto Nacional de Alergia y Enfermedades Infecciosas (NIAID) de los Estados Unidos,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: STAGE 1 4.1.1 INCLUSION CRITERIA FOR HIV-1 INFECTED INDIVIDUALS ON HAART 1. HIV-1 INFECTION, AS DOCUMENTED BY ANY LICENSED ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) TEST KIT AND CONFIRMED BY WESTERN BLOT AT ANY TIME PRIOR TO STUDY ENTRY. HIV-1 CULTURE, HIV-1 ANTIGEN, PLASMA HIV-1 RNA, OR A SECOND ANTIBODY TEST BY A METHOD OTHER THAN ELISA IS ACCEPTABLE AS AN ALTERNATIVE CONFIRMATORY TEST. 2. INITIATED HAART WITHIN ONE YEAR PRIOR TO STUDY ENTRY. HAART IS DEFINED AS A REGIMEN CONSISTING OF THE FOLLOWING DRUG(S) AND/OR DRUG CLASSES: 2 NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NRTIs) TOGETHER WITH A) A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI); B) AT LEAST ONE PROTEASE INHIBITOR (PI); C) AT LEAST ONE INTEGRASE OR ENTRY INHIBITOR. A REGIMEN CONTAINING AN NRTI, NNRTI, AND A PI OR AN NRTI, NNRTI AND AT LEAST ONE INTEGRASE OR ENTRY INHIBITOR IS ALSO ACCEPTABLE. 3. MEN AN WOMEN WHO HAVE REACHED THE LEGAL AGE OF MAJORITY IN THE COUNTRY WHERE THEY ARE BEING ENROLLED. 4. ABILITY AND WILLINGNESS OF POTENTIAL PARTICIPANT TO PROVIDE INFORMED CONSENT. 5. WILLINGNESS TO DISCUSS PERSONAL TOPICS DURING AN AUDIO-TAPED GROUP INTERVIEW. 6. WILLINGNESS TO PROTECT THE CONFIDENTIALITY OF OTHER FOCUS GROUP PARTICIPANTS.

Exclusion criteria

Exclusion criteria: 4.2 EXCLUSION CRITERIA - STAGE 1 4.2.1 EXCLUSION CRITERIA FOR HIV-1 INFECTED INDIVIDUALS ON HAART 1. FAILURE TO REMAIN ON HAART FOR AT LEAST THIRTY CONSECUTIVE DAYS. 2. DIMINISHED COGNITIVE CAPACITY THAT, IN THE OPINION OF THE SCREENING CRS CLINICIAN, WOULD INTERFERE WITH STUDY PARTICIPATION. 3. PARTICIPATION IN ANY PRIOR A5250 FOCUS GROUP. 4.2.2 EXCLUSION CRITERIA FOR HEALTCARE PROVIDERS/PROFESSIONALS 1. HEALTCARE PROVIDERS/PROFESSIONALS WHO WILL BE INVOLVED IN ADMINISTERING SOC TREATMENT AND ADHERENCE COUNSELING TO STAGE 2 PARTICIPANTS RANDOMIZED TO THE SOC ARM OR CRS INVESTIGATORS OR HEALTCARE PROVIDERS/PROFESSIONALS DIRECTLY INVOLVED IN MEASURING ADHERENCE OUTCOMES IN STAGE 2. 2. PARTICIPATION IN ANY PRIOR A5250 FOCUS GROUP.

Countries

India, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)