Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Behavioral: Directly Observed Therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | DOT-HAART for HIV-Infected South African Adults |
- Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment [ Time Frame: at 12 and 24 months of treatment ] [ Designated as safety issue: No ]Proportion of Patients with HIV RNA Levels of <400 at 12 Months - Intention-to-treat
- Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ]Proportion of Patients with HIV RNA Levels of <400 Copies/mL at 24 Months [Intention-to-treat (ITT)
- Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Enrollment: | 274 |
| Study Start Date: | February 2005 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| South Africa | |
| University of Cape Town | |
| Cape Town, South Africa, 7925 | |
| Principal Investigator: | Richard E Chaisson, MD | Johns Hopkins University |
More Information
Additional Information:
Publications:
| Responsible Party: | Dr. Richard Chaisson, Director, Center for TB Research, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00076804 History of Changes |
| Other Study ID Numbers: | 1R01AI055359-01A1, 1 R01 AI055359-01A1 |
| Study First Received: | February 3, 2004 |
| Results First Received: | June 1, 2010 |
| Last Updated: | April 23, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Johns Hopkins University:
|
Directly Observed Therapy DOT |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on March 14, 2013
