Clinical trial NCT00076804: Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
Official title: DOT-HAART for HIV-Infected South African Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Directly Observed Therapy
DOT
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of Cape Town
First posted: 2004-02-06
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Three or more anti-HIV drugs are taken in combination as part of a treatment regimen. These drug regimens must be closely followed in order to be successful. Having a support person watch a patient take his or her anti-HIV drugs each day may help a patient follow his or her regimen. This study will see if patient-chosen treatment supporters help patients take HIV medicines correctly and improve their health.

Study hypothesis: The mean change in CD4 count at 12 and 24 months will be significantly higher in the directly observed therapy-highly active antiretroviral therapy (DOT-HAART) arm as compared to the self-administered arm.

Detailed description: South Africa has one of the worst and fastest growing HIV epidemics in the world. Highly active antiretroviral therapy (HAART) has been shown both at the individual and public health levels to reduce morbidity, mortality, and vertical and possibly horizontal HIV transmission. However, expenses, feasibility, long-term adherence, and effective delivery of HAART remain formidable barriers, particularly in developing nations. Recently, international initiatives have provided hope for widespread use of HAART at affordable cost in sub-Saharan Africa. Simplified, once-daily HAART regimens with directly observed therapy (DOT) may help to achieve high levels of treatment adherence, a key component for long-term viral suppression and treatment success. Peer advocates have been used to improve adherence with medical therapies in a variety of settings. This study will evaluate the effectiveness and feasibility of DOT using patient-nominated peer supervisors to improve adherence to HAART in HIV infected adults in South Africa.

Participants will be randomly assigned to either Peer-DOT-HAART or self-administration of a once-daily combination of the Western Cape Province ART program medications for 24 months. Study measures will include CD4 cell count and HIV viral load, adherence questionnaires, genotypic HAART resistance testing, and incidence of new or recurrent opportunistic infections.

Eligibility criteria: Inclusion Criteria:

* HIV infected
* Viral load greater than 1000 copies/ml
* CD4 count of 200 cells/mm3 or less, or World Health Organization Stage 4 disease
* Living in the area of the study site
* Had a known address for more than 3 months
* Willing to nominate a treatment supervisor (a close family member, sexual partner, friend, or community volunteer) to observe daily ingestion of tablets
* Willing to disclose HIV status to a treatment supervisor and ready to commit to long-term antiretroviral therapy
* Acceptable methods of contraception

Exclusion Criteria:

* Pregnant

Primary outcomes:
measure: Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment
timeFrame: at 12 and 24 months of treatment
measure: Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment
timeFrame: 24 months
measure: Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm
timeFrame: 12 months
measure: Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: University of Cape Town
Study officials:
affiliation: Johns Hopkins University
name: Richard E Chaisson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nachega JB, Chaisson RE, Goliath R, Efron A, Chaudhary MA, Ram M, Morroni C, Schoeman H, Knowlton AR, Maartens G. Randomized controlled trial of trained patient-nominated treatment supporters providing partial directly observed antiretroviral therapy. AIDS. 2010 Jun 1;24(9):1273-80. doi: 10.1097/QAD.0b013e328339e20e.