Randomised Controlled Trial on Highly Active AntiRetroviral Therapy (HAART), social networks, and adherence in Mozambique

ISRCTN	ISRCTN78797542
DOI	https://doi.org/10.1186/ISRCTN78797542
ClinicalTrials.gov number	NCT00272220
Secondary identifying numbers	N/A

Submission date: 22/12/2005
Registration date: 31/01/2006
Last edited: 28/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Ms Cynthia Pearson
Scientific

Department of Psychology
University of Washington
Box 351525
Seattle, Washington
98105-1525
United States of America

Phone	+1 206 330 1997
Email	pearsonc@u.washington.edu

Study information

Study design	Two-armed randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Screening
Scientific title	A randomized control trial of peer-delivered modified directly observed therapy for HAART in Mozambique.
Study hypothesis	Our hypothesis is that modified Directly Observed Therapy (mDOT) during the initial six weeks of HAART, supervised primarily by Human Immunodeficiency Virus (HIV) positive lay activists, will improve adherence and clinical outcomes compared with those that do not have supervised mDOT. We also hypothesize that the benefits of mDOT will be achieved through a variety of mediators that will result from the social interactions the patients will have with the activists. These mediators include: improved social support, improved knowledge about HAART, reduced stigma, and improved self-efficacy.
Ethics approval(s)	Human Subjects Division (HSD), Washington, number 03-9137-G 01; 18/12/2003
Condition	Adherence to highly active antiretroviral therapy (HAART)
Intervention	The project is a randomized controlled trial among a sample of HIV positive antiretroviral-naive patients newly starting HAART, randomized to either receive six weeks of modified DOT in addition to standard clinical and adherence support, or standard care only. The package of standard care includes: clinical and laboratory assessments related to starting and monitoring HAART, including follow-up consults every month for three months, followed by every three months thereafter, and Cluster of Differentiation-4 (CD4) testing at pre-initiation of HAART and every six months. Pre-HAART adherence assessment, with a social worker, during which AntiRetroViral (ARV) treatment is explained, expectations clarified, and barriers to adherence identified and addressed. A method of patient localization is also required, which may include leaving a phone number or, in cases where phones are not available, a home visit. Treatment partners are recommended but not required. Post-HAART adherence support is provided through counseling by all members of the healthcare team, including the physician or physicians assistant during regularly scheduled clinic appointments, and a pharmacist or pharmacy technician and social worker at the time of each medication refills. Additional visits are performed as needed by a social worker and activists, who may become involved in cases of poor adherence. Referrals to community-based organizations for adherence support may also be performed. In addition to this standard package of care, the patients are randomized to the intervention group will receive six weeks of modified DOT. Modified DOT includes supervising, via direct observation, the morning weekday doses of patients medications in the clinic, while night time and weekend doses are self-administered. The six-week timeframe for mDOT was chosen to cover the initial time of treatment when the importance of adherence may be heightened, when side effects leading to poor adherence may be most pronounced, and when chronic pill-taking behaviors may be reinforced. The direct observation will be performed primarily by DOT activists, who are full-time paid HIV-positive lay employees of the clinic whose primary job is to ensure the adherence of patients on HAART. During DOT sessions, their interactions with patients are to include, in addition to supervising and recording the swallowing of pills, counseling and educating patients regarding general HIV-related information, their treatment, and care plan. Patients not reporting to clinic to take their medication during DOT are located on the same day by the activists usually through home visits or phone calls (if possible). Such patients are also brought their dose of medication to take, and the activists reinforce the importance of good adherence.
Intervention type	Other
Primary outcome measure	Adherence to treatment: increase in both short (six months) and long term (one year) adherence to HAART treatment
Secondary outcome measures	Improvement in clinical outcomes associated with HAART therapy
Overall study start date	01/10/2004
Overall study end date	30/08/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	367
Participant inclusion criteria	1. Persons initiating HAART 2. Adults and children 18 years or older 3. Patients living near the geographical area of the study sites Beira, Mozambique, whereby making daily clinic visits if randomized to receive DOT would be possible 4. Agreement to participate in DOT if randomized to that arm of the study
Participant exclusion criteria	1. Psychotic or demented 2. Not willing or able to provide consent to participate
Recruitment start date	01/10/2004
Recruitment end date	30/08/2006

Locations

Countries of recruitment

United States of America

Study participating centre

Department of Psychology

Seattle, Washington
98105-1525
United States of America

Sponsor information

University of Washington/Health Alliance International (USA)
University/education

1107 NE 45th street
Suite 427
Seattle, Washington
98105
United States of America

Phone	+1 206 543 8382
Email	mmicek@u.washington.edu
Website	http://depts.washington.edu/haiuw/
"ROR"	https://ror.org/00cvxb145

Funders

Funder type

Government

Health Alliance International funding through President's Emergency Plan for AIDS Relief (PEPFAR) 1.5, quick start HIV/AIDS Rapid Expansion Program and TAPS

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2007	28/01/2019	Yes	No

Editorial Notes

28/01/2019: Publication reference added