Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02135003
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Rakai Health Sciences Program

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


Condition or disease Intervention/treatment Phase
CD4 Deficiency Adherence Quality of Life Other: patient-selected care buddy Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1209 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Non-enrolment and Non-adherence to HIV Care in a Community-based Program, Rakai, Uganda
Study Start Date : October 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Buddy arm, Standard of care arm

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
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




Primary Outcome Measures :
  1. HIV disease progression to eligibility for anti-retroviral therapy [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. adherence to clinic appointments [ Time Frame: 12 months ]
    patient adherence to CD4 blood draw appointments

  2. patient quality of life [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135003


Locations
Layout table for location information
Uganda
Rakai Health Sciences Program
Kalisizo, Rakai, Uganda, 279
Sponsors and Collaborators
Rakai Health Sciences Program
Investigators
Layout table for investigator information
Principal Investigator: Gertrude Nakigozi, MBChB,MPH Rakai Health Sciences Program
Layout table for additonal information
Responsible Party: Rakai Health Sciences Program
ClinicalTrials.gov Identifier: NCT02135003    
Other Study ID Numbers: 1110
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014