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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00648232 |
Purpose
This study will compare the effectiveness of brief versus detailed HIV counseling sessions, paired with referrals to either HIV-specific medical care or usual care, in reducing HIV risk behavior and in increasing treatment adherence in Uganda.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Behavioral: Voluntary brief HIV counseling and testing Behavioral: Voluntary longer, more detailed HIV counseling and testing Behavioral: Enhanced linkage to care Behavioral: Routine referral to care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Inpatient HIV Counseling and Testing and Linkage to Care in Uganda |
| Estimated Enrollment: | 3314 |
| Study Start Date: | May 2008 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Participants will receive voluntary brief HIV counseling and testing plus enhanced linkage to care.
|
Behavioral: Voluntary brief HIV counseling and testing
Participants will receive 10 to 15 minutes of pretest counseling on the importance of HIV testing and on available services for people infected with HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
Behavioral: Enhanced linkage to care
Participants will be provided with more detailed counseling on how to access HIV services, will be introduced to a specific HIV clinic, and will be given a list of other HIV services available in the area. After leaving the hospital, participants will receive reminder telephone calls 1 week before their scheduled visits at the HIV clinics.
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Experimental: B
Participants will receive voluntary brief HIV counseling and testing plus routine referral to care.
|
Behavioral: Voluntary brief HIV counseling and testing
Participants will receive 10 to 15 minutes of pretest counseling on the importance of HIV testing and on available services for people infected with HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
Behavioral: Routine referral to care
Participants will be provided with information on the importance of receiving HIV care and will be given a list of available HIV area services.
|
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Experimental: C
Participants will receive voluntary longer, more detailed HIV counseling and testing plus enhanced linkage to care.
|
Behavioral: Voluntary longer, more detailed HIV counseling and testing
Participants will receive 45 to 60 minutes of pretest counseling on general HIV/AIDS information and testing for HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
Behavioral: Enhanced linkage to care
Participants will be provided with more detailed counseling on how to access HIV services, will be introduced to a specific HIV clinic, and will be given a list of other HIV services available in the area. After leaving the hospital, participants will receive reminder telephone calls 1 week before their scheduled visits at the HIV clinics.
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Experimental: D
Participants will receive voluntary longer, more detailed HIV counseling and testing plus routine referral to care.
|
Behavioral: Voluntary longer, more detailed HIV counseling and testing
Participants will receive 45 to 60 minutes of pretest counseling on general HIV/AIDS information and testing for HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
Behavioral: Routine referral to care
Participants will be provided with information on the importance of receiving HIV care and will be given a list of available HIV area services.
|
|
Active Comparator: E
Participants who are found to be healthy will receive voluntary brief HIV counseling and testing only.
|
Behavioral: Voluntary brief HIV counseling and testing
Participants will receive 10 to 15 minutes of pretest counseling on the importance of HIV testing and on available services for people infected with HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
|
|
Active Comparator: F
Participants who are found to be healthy will receive voluntary longer, more detailed HIV counseling and testing only.
|
Behavioral: Voluntary longer, more detailed HIV counseling and testing
Participants will receive 45 to 60 minutes of pretest counseling on general HIV/AIDS information and testing for HIV. After pretest counseling, participants will undergo a blood draw for HIV testing. Participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
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HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. HIV is a major global health concern, with countries in Africa undergoing a severe HIV/AIDS crisis. The number of new cases of HIV infection in Africa continues to rise, making disease prevention methods imperative. Important to the prevention process are early testing, educational counseling on HIV and how to reduce sexual-risk behavior, and connecting people with HIV infection to services that offer medical treatment and social support. However, the most effective strategy for fully integrating HIV counseling, testing, and medical care access is not known. This study will compare the effectiveness of brief versus detailed HIV counseling sessions, paired with either referrals to HIV-specific medical care or usual care, in reducing HIV risk behavior and in increasing treatment adherence in Uganda.
Participation in this study will last 12 months. All participants will undergo an initial interview to obtain basic information on previous HIV testing and status. Participants will then be assigned randomly to receive a brief or more detailed counseling session given before and after HIV testing. Participants assigned to the brief counseling session will receive 10 to 15 minutes of pretest counseling on the importance of HIV testing and available services for people infected with HIV. Participants assigned to the detailed counseling session will receive 45 to 60 minutes of pretest counseling on general HIV/AIDS information and testing for HIV. After pretest counseling, participants in both groups will undergo a blood draw for HIV testing. All participants will receive test results and additional counseling 1 hour after the blood sample is drawn.
Participants who are found to be infected with HIV will be assigned randomly to receive enhanced referrals to HIV-specific medical care or referrals to usual care. Participants receiving the enhanced referrals will be provided with more detailed counseling on how to access HIV services, will be introduced to a specific HIV clinic, and will be given a list of other HIV services available in the area. After leaving the hospital, participants will receive reminder telephone calls 1 week before their first scheduled visits at the HIV clinics. Participants receiving referrals to usual care will be provided with information on the importance of receiving HIV care and will be given a list of available HIV area services. At Months 3, 6, 9, and 12, participants in both groups will be interviewed about contact information, overall health, current medications, sexual history, health services utilized, and any repeat HIV tests. Participants who are not infected with HIV may be randomly selected to undergo the same follow-up interviews as the HIV infected participants.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Thomas J. Coates, PhD | 310-794-3580 | tcoates@mednet.ucla.edu |
| Contact: Sharif R. Sawires, MA | 310-794-2676 | ssawires@mednet.ucla.edu |
| Uganda | |
| Makerere University/Mulago Teaching Hospital, Uganda | Recruiting |
| Kampala, Uganda, 7072 | |
| Contact: Rhoda Wanyenze, MBChB, MPH rwanyenze@mjap.or.ug | |
| Principal Investigator: | Thomas J. Coates, PhD | UCLA David Geffen School of Medicine |
More Information
| Responsible Party: | Thomas J. Coates, Professor, UCLA David Geffen School of Medicine, Division of Medicine |
| ClinicalTrials.gov Identifier: | NCT00648232 History of Changes |
| Other Study ID Numbers: | R01 MH077512, DABHR 9A-ASGA |
| Study First Received: | March 28, 2008 |
| Last Updated: | March 9, 2009 |
| Health Authority: | United States: Federal Government |
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HIV AIDS Prevention VCT Voluntary Counseling and Testing |
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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 |