Condition category
Infections and Infestations
Date applied
22/12/2005
Date assigned
31/01/2006
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Cynthia Pearson

ORCID ID

Contact details

Department of Psychology
University of Washington
Box 351525
Seattle
Washington
98105-1525
United States of America
+1 206 330 1997
pearsonc@u.washington.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00272220

Protocol/serial number

N/A

Study information

Scientific title

Acronym

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

Human Subjects Division (HSD), Washington, number 03-9137-G 01; 18/12/2003

Study design

Two-armed randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Screening

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/2004

Overall trial end date

30/08/2006

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

367

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

Trial participating centre

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

Sponsor information

Organisation

University of Washington/Health Alliance International (USA)

Sponsor details

1107 NE 45th street
Suite 427
Seattle
Washington
98105
United States of America
+1 206 543 8382
mmicek@u.washington.edu

Sponsor type

University/education

Website

http://depts.washington.edu/haiuw/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes