Non-enrolment and Non-adherence to HIV Care in a Community-based Program, Rakai, Uganda

NCT02135003 | Completed

• 1 other identifier: 1110
• Study Type: interventional
• Target: 1,209
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis 1: The proportion of pre-ART patients whose CD4 cell counts decline to ART-eligibility within 48 weeks will be lower in intervention compared to the non-intervention arm. Hypothesis 2: PLHIV who receive the PSCB intervention will experience lower rates of morbidity or death over the follow-up period compared to patients not receiving the intervention Hypothesis 3: PLHIV who receive the PCSB intervention will have better adherence to scheduled clinic appointments compared to those not receiving the intervention

Conditions

CD4 Deficiency; Adherence; Quality of Life

Outcome Measures

Primary Outcomes (1)

• HIV disease progression to eligibility for anti-retroviral therapy

  12 months

Secondary Outcomes (2)

• adherence to clinic appointments

  12 months

• patient quality of life

  12 months

Study Arms (1)

Buddy arm, Standard of care arm

EXPERIMENTAL

Standard of care: Patients enrolled for pre-ART care received general health education, clinical monitoring, CD4 testing and other clinically indicated investigations, treatment of opportunistic infections, and cotrimoxazole prophylaxis. Patient-selected Care buddy intervention: In addition to standard of care, pre-ART patients randomized to this arm were requested to choose a care buddy who was aware of the patient's HIV infection and resided in the same household or in close proximity. buddies attended at least two HIV health education. Information on HIV, and the importance of adhering to scheduled clinic visits and to prescribed medications will be emphasized. Buddies were requested to remind participants to take their prophylactic treatments, and remind them of clinic appointments

Other: patient-selected care buddy

Interventions

patient-selected care buddy OTHER

Patient-selected Care buddy intervention: In addition to standard of care, pre-ART patients randomized to this arm were requested to choose a care buddy who was aware of the patient's HIV infection and resided in the same household or in close proximity. Care buddies attended at least two HIV health education sessions similar to those provided to study participants. Information on HIV, and the importance of adhering to scheduled clinic visits and to prescribed medications will be emphasized. Buddies were requested to remind participants to take their prophylactic treatments, and remind them of clinic appointments

Buddy arm, Standard of care arm

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• pre-ART patients aged 15 years or older, with CD4 count of 251+ cells/ul (not eligible to start ART according to the Rakai program criteria of CD4≤250 or WHO stage IV)
• provide informed consent or assent
• able to provide a care buddy

You may not qualify if:

• on ART
• cd4 count \<250 cells/ul
• unable to provide consent/assent
• unable to provide a buddy

Sponsors & Collaborators

• Rakai Health Sciences Program: lead

Study Sites (1)

Rakai Health Sciences Program

Kalisizo, Rakai, 279, Uganda

Location

Study Officials

• Gertrude Nakigozi, MBChB,MPH

  Rakai Health Sciences Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 9, 2014
• Study Start: October 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 9, 2014

Record last verified: 2014-05

Locations

UG (1)