HIV InfectionsNCT00648232
HIV Counseling and Testing and Linkage to Care in Uganda
A study testing Voluntary brief HIV counseling and testing, Voluntary longer, more detailed HIV counseling and testing and Enhanced linkage to care in people with HIV Infections, run by University of California, Los Angeles at 1 site in Uganda.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Voluntary brief HIV counseling and testing, Voluntary longer, more detailed HIV counseling and testing and Enhanced linkage to care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,415 participants
- Where
- 1 siteUganda
- Study dates
- May 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Makerere University/Mulago Teaching Hospital, Uganda
Kampala, 7072
About this study
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.
Read the detailed description
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.
- Conditions
- HIV Infections
- Being tested
- Voluntary brief HIV counseling and testing, Voluntary longer, more detailed HIV counseling and testing, Enhanced linkage to care, Routine referral to care
- Keywords
- HIV, AIDS, Prevention, VCT, Voluntary Counseling and Testing
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voluntary brief HIV counseling and testingBehavioural
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.
Voluntary longer, more detailed HIV counseling and testingBehavioural
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.
Enhanced linkage to careBehavioural
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.
Routine referral to careBehavioural
Participants will be provided with information on the importance of receiving HIV care and will be given a list of available HIV area services.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Participants will receive voluntary brief HIV counseling and testing plus enhanced linkage to care. Receives: Behavioral: Voluntary brief HIV counseling and testing; Behavioral: Enhanced linkage to care |
| B | Experimental | Participants will receive voluntary brief HIV counseling and testing plus routine referral to care. Receives: Behavioral: Voluntary brief HIV counseling and testing; Behavioral: Routine referral to care |
| C | Experimental | Participants will receive voluntary longer, more detailed HIV counseling and testing plus enhanced linkage to care. Receives: Behavioral: Voluntary longer, more detailed HIV counseling and testing; Behavioral: Enhanced linkage to care |
| D | Experimental | Participants will receive voluntary longer, more detailed HIV counseling and testing plus routine referral to care. Receives: Behavioral: Voluntary longer, more detailed HIV counseling and testing; Behavioral: Routine referral to care |
| E | Active comparator | Participants who are found to be healthy will receive voluntary brief HIV counseling and testing only. Receives: Behavioral: Voluntary brief HIV counseling and testing |
| F | Active comparator | Participants who are found to be healthy will receive voluntary longer, more detailed HIV counseling and testing only. Receives: Behavioral: Voluntary longer, more detailed HIV counseling and testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in HIV risk behavior among inpatients after discharge
Measured: Measured at Months 3, 6, 9, and 12
Receipt of opportunistic infection (OI) prophylaxis, adherence to antiretroviral therapy (ART), and reduction in mortality
Measured: Measured at Months 3, 6, 9, and 12
Secondary outcomes (1)
Number of infections averted per patient randomized to each of the four intervention strategies
Measured: Measured at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3,415 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Thomas J. Coates, University of California, Los Angeles
- Investigators
- Thomas J. Coates, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648232
- Sponsor's protocol ID
- R01MH077512
- Other IDs
- R01MH077512, DABHR 9A-ASGA
- Status last verified
- Dec 2013
- First submitted
- 28 Mar 2008
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wanyenze RK, Kamya MR, Fatch R, Mayanja-Kizza H, Baveewo S, Szekeres G, Bangsberg DR, Coates T, Hahn JA. Abbreviated HIV counselling and testing and enhanced referral to care in Uganda: a factorial randomised controlled trial. Lancet Glob Health. 2013 Sep;1(3):e137-45. doi: 10.1016/S2214-109X(13)70067-6. Epub 2013 Aug 23.
PubMed 25104262
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Counseling and Testing and Linkage to Care in Uganda
- ClinicalTrials.gov ID
- NCT00648232
- Acronym / sponsor ID
- R01MH077512
- Conditions
- HIV Infections
- Keywords
- HIV, AIDS, Prevention, VCT, Voluntary Counseling and Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,415 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Voluntary brief HIV counseling and testing, Behavioral: Enhanced linkage to careParticipants will receive voluntary brief HIV counseling and testing plus enhanced linkage to care. |
| B | Experimental | Behavioral: Voluntary brief HIV counseling and testing, Behavioral: Routine referral to careParticipants will receive voluntary brief HIV counseling and testing plus routine referral to care. |
| C | Experimental | Behavioral: Voluntary longer, more detailed HIV counseling and testing, Behavioral: Enhanced linkage to careParticipants will receive voluntary longer, more detailed HIV counseling and testing plus enhanced linkage to care. |
| D | Experimental | Behavioral: Voluntary longer, more detailed HIV counseling and testing, Behavioral: Routine referral to careParticipants will receive voluntary longer, more detailed HIV counseling and testing plus routine referral to care. |
| E | Active comparator | Behavioral: Voluntary brief HIV counseling and testingParticipants who are found to be healthy will receive voluntary brief HIV counseling and testing only. |
| F | Active comparator | Behavioral: Voluntary longer, more detailed HIV counseling and testingParticipants who are found to be healthy will receive voluntary longer, more detailed HIV counseling and testing only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voluntary brief HIV counseling and testingParticipants 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. | Behavioural | A, B, E |
| Voluntary longer, more detailed HIV counseling and testingParticipants 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. | Behavioural | C, D, F |
| Enhanced linkage to careParticipants 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. | Behavioural | A, C |
| Routine referral to careParticipants will be provided with information on the importance of receiving HIV care and will be given a list of available HIV area services. | Behavioural | B, D |
Primary outcome
Reduction in HIV risk behavior among inpatients after discharge
Time frame: Measured at Months 3, 6, 9, and 12
Receipt of opportunistic infection (OI) prophylaxis, adherence to antiretroviral therapy (ART), and reduction in mortality
Time frame: Measured at Months 3, 6, 9, and 12
1 secondary outcome
Number of infections averted per patient randomized to each of the four intervention strategies
Time frame: Measured at Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
- Derived from this study: PubMed 25104262Wanyenze RK, Kamya MR, Fatch R, Mayanja-Kizza H, Baveewo S, Szekeres G, Bangsberg DR, Coates T, Hahn JA. Abbreviated HIV counselling and testing and enhanced referral to care in Uganda: a factorial randomised controlled trial. Lancet Glob Health. 2013 Sep;1(3):e137-45. doi: 10.1016/S2214-109X(13)70067-6. Epub 2013 Aug 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J. Coates, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voluntary brief HIV counseling and testing, Voluntary longer, more detailed HIV counseling and testing and Enhanced linkage to care in people with HIV Infections, run by University of California, Los Angeles at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in HIV risk behavior among inpatients after discharge (time frame: Measured at Months 3, 6, 9, and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00648232, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2013.