Helping HIV Infected Patients in South Africa Adhere to Drug Regimens

HIV Infections Clinical Trial

Official title:

DOT-HAART for HIV-Infected South African Adults

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00076804
• Other study ID #: 1R01AI055359-01A1
• Secondary ID: 1R01AI055359-01A
• Status: Terminated
• Phase: Phase 2
• First received: February 3, 2004
• Last updated: March 9, 2015
• Start date: February 2005
• Est. completion date: September 2008

Study information

• Verified date: March 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 274
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Directly Observed Therapy
Use of a patient nominated peer supporter who will observe the morning dose of ARVs

Locations

Country	Name	City	State
South Africa	University of Cape Town	Cape Town

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	University of Cape Town

Country where clinical trial is conducted

South Africa, 

References & Publications (1)

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. AID — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm		12 months	No
Primary	Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm		24 months	No

External Links

•   Click here for more information on adherence
•   Click here for more information on adhering to a regimen