Helping HIV Infected Patients in South Africa Adhere to Drug Regimens

DOT-HAART for HIV-Infected South African Adults

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.

Study Overview

• Status: Terminated
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Directly Observed Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 274
• Phase: Phase 2

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa, 7925
    • University of Cape Town

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Use of a patient nominated peer supporter who will observe the morning dose of ARVs	Behavioral: Directly Observed Therapy; Use of a patient nominated peer supporter who will observe the morning dose of ARVs
No Intervention: 2; Self administration of ARVs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment	Proportion of Patients with HIV RNA Levels of <400 at 12 Months - Intention-to-treat	at 12 and 24 months of treatment
Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment	Proportion of Patients with HIV RNA Levels of <400 Copies/mL at 24 Months [Intention-to-treat (ITT)	24 months
Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm		12 months
Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm		24 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: University of Cape Town
• Investigators: Principal Investigator: Richard E Chaisson, MD, Johns Hopkins University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: February 3, 2004
• First Submitted That Met QC Criteria: February 5, 2004
• First Posted (Estimate): February 6, 2004

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Directly Observed Therapy; DOT
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 1R01AI055359-01A1 (U.S. NIH Grant/Contract)