- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00648232
HIV Counseling and Testing and Linkage to Care in Uganda
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Kampala, Uganda, 7072
- Makerere University/Mulago Teaching Hospital, Uganda
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Willing to receive HIV test results
- Willing to provide adequate contact information
- Possesses sufficient cognitive ability to provide informed consent and participate in the interventions, as determined subjectively by the Regulatory Coordinator (patient with altered mental status or who is otherwise too ill to participate in the consent process will be excluded)
- Planned local residence over the next year after study entry (within a reasonable distance; approximate radius of 25 km of Kampala city center)
- Fluent in Luganda or English
Exclusion Criteria:
- Self-reported HIV-infected serostatus (defined as ever receiving an HIV-positive test result)
- Self-reported HIV test within the 12 months before study entry
- Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: A
Participants will receive voluntary brief HIV counseling and testing plus enhanced linkage to care.
|
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.
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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Eksperimentel: B
Participants will receive voluntary brief HIV counseling and testing plus routine referral to care.
|
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.
Participants will be provided with information on the importance of receiving HIV care and will be given a list of available HIV area services.
|
|
Eksperimentel: C
Participants will receive voluntary longer, more detailed HIV counseling and testing plus 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.
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.
|
|
Eksperimentel: D
Participants will receive voluntary longer, more detailed HIV counseling and testing plus 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.
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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Aktiv komparator: E
Participants who are found to be healthy will receive voluntary brief HIV counseling and testing only.
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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.
|
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Aktiv komparator: F
Participants who are found to be healthy will receive voluntary longer, more detailed HIV counseling and testing only.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Reduction in HIV risk behavior among inpatients after discharge
Tidsramme: Measured at Months 3, 6, 9, and 12
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Measured at Months 3, 6, 9, and 12
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Receipt of opportunistic infection (OI) prophylaxis, adherence to antiretroviral therapy (ART), and reduction in mortality
Tidsramme: Measured at Months 3, 6, 9, and 12
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Measured at Months 3, 6, 9, and 12
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Number of infections averted per patient randomized to each of the four intervention strategies
Tidsramme: Measured at Month 12
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Measured at Month 12
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Thomas J. Coates, PhD, UCLA David Geffen School of Medicine
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01MH077512 (U.S. NIH-bevilling/kontrakt)
- DABHR 9A-ASGA
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