Helping HIV Infected Patients in South Africa Adhere to Drug Regimens

NCT ID: NCT00076804

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2008-09-30

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Use of a patient nominated peer supporter who will observe the morning dose of ARVs

Group Type: EXPERIMENTAL

Directly Observed Therapy

Intervention Type: BEHAVIORAL

Use of a patient nominated peer supporter who will observe the morning dose of ARVs

2

Self administration of ARVs

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Directly Observed Therapy

Use of a patient nominated peer supporter who will observe the morning dose of ARVs

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cape Town

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Richard Chaisson

Director, Center for TB Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard E Chaisson, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

University of Cape Town

Cape Town, , South Africa

Countries

South Africa

References

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.

Reference Type: RESULT

PMID: 20453627 (View on PubMed)

Other Identifiers

1R01AI055359-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01AI055359-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link