HIVNCT02497456
The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda
A study testing Follow-up counselling in people with HIV, run by MRC/UVRI and LSHTM Uganda Research Unit at 1 site in Uganda.
Trial summary
The purpose of this study is to evaluate the impact of follow-up counselling after HIV diagnosis through home-based HIV counselling and testing (HBHCT), on linkage to pre-antiretroviral therapy (pre-ART) care 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
- What is being tested?
- Follow-up counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteUganda
- Study dates
- Mar 2015to Mar 2016
- 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
- HIV-infected adult (≥18 years)
- Willing to provide informed consent
- Willing to receive follow-up counselling at home
- HIV negative adult (≥18 years)
- Willing to provide informed consent
- Willing to receive follow-up counselling at home
Who cannot join
- Previous or current receipt of HIV care from an ART provider
- On-going participation in other health-related research
- Intending to change residence in the next 6 months
- Conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness
- HIV-uninfected participants
- Intending to change residence in the next 6 months
- Conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the impact of follow-up counselling after HIV diagnosis through home-based HIV counselling and testing (HBHCT), on linkage to pre-antiretroviral therapy (pre-ART) care in Uganda.
Read the detailed description
Data on linkage to pre-antiretroviral therapy (pre-ART) care after HIV diagnosis through home-based HIV counselling and testing (HBHCT) in sub-Saharan Africa (SSA) are scarce. The few existing data suggest that only 13% to 54% of HIV-infected persons identified through HBHCT enter pre-ART care. No studies have rigorously evaluated interventions aimed at improving linkage to pre-ART care following HBHCT in SSA. This study will evaluate the effect of follow-up counselling after HIV diagnosis through HBHCT on linkage to pre-ART care in Masaka, south-western Uganda.
The study is a cluster randomised trial of the effectiveness of referral to pre-ART care and follow-up counselling (intervention) compared to referral to pre-ART care only (control), for individuals diagnosed with HIV through HBHCT. The intervention will be administered at months 1 and 2, and linkage to care assessed at month 6 post-HBHCT. Data will be collected on socio-demographic characteristics, sexual risk profile, HIV testing history, HIV status disclosure, linkage to care, CD4 count testing and results, cotrimoxazole prophylaxis, and ART initiation. At least 224 HIV-infected participants will be enrolled from 28 clusters (14/study arm). Approximately 84 HIV-uninfected individuals will also be recruited into the study to reduce the possibility of revealing the sero-status of the HIV-infected participants.
- Conditions
- HIV
- Being tested
- Follow-up counselling
- Keywords
- HIV, Counselling, Care, antiretroviral therapy, linkage, Uganda, Africa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up counsellingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Follow-up counselling | Experimental | Participants in the experimental arm will receive home-based HIV counselling and testing and referral for HIV care if found to have HIV infection. Additionally, participants will receive home-based follow-up counselling at 1 and 2 months after HIV diagnosis. Receives: Behavioral: Follow-up counselling |
| Standard of care | No intervention | Participants in this arm will receive only home-based HIV counselling and testing and referral for HIV care if found to have HIV infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of HIV-infected participants that register with an anti-retroviral therapy (ART) care provider within 3 and 6 months of HIV diagnosis and referral.
Measured: 6 months
The time between HIV diagnosis and linkage to pre-ART care.
Measured: 6 months
Secondary outcomes (3)
Time between blood draw for CD4 cell count testing and attending clinic to receive the results among participants that link to pre-ART care
Measured: 6 months
The time between learning that a participant is eligible for ART and ART initiation
Measured: 6 months
The proportion of participants who report adherence to daily cotrimoxazole prophylaxis at 3 and 6 months after HIV diagnosis through HBHCT among those that link to pre-ART care.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
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 HIVStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- MRC/UVRI and LSHTM Uganda Research Unit
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- Eugene Ruzagira, Principal investigator, MRC/UVRI and LSHTM Uganda Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497456
- Sponsor's protocol ID
- Linkage to pre-ART care
- Status last verified
- Mar 2016
- First submitted
- 6 Jul 2015
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ruzagira E, Grosskurth H, Kamali A, Baisley K. Brief counselling after home-based HIV counselling and testing strongly increases linkage to care: a cluster-randomized trial in Uganda. J Int AIDS Soc. 2017 Oct;20(2):e25014. doi: 10.1002/jia2.25014.
PubMed 29052344
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda
- ClinicalTrials.gov ID
- NCT02497456
- Acronym / sponsor ID
- Linkage to pre-ART care
- Conditions
- HIV
- Keywords
- HIV, Counselling, Care, antiretroviral therapy, linkage, Uganda, Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- MRC/UVRI and LSHTM Uganda Research UnitUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Jul 2015 (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.
The purpose of this study is to evaluate the impact of follow-up counselling after HIV diagnosis through home-based HIV counselling and testing (HBHCT), on linkage to pre-antiretroviral therapy (pre-ART) care in Uganda.
Detailed description
Data on linkage to pre-antiretroviral therapy (pre-ART) care after HIV diagnosis through home-based HIV counselling and testing (HBHCT) in sub-Saharan Africa (SSA) are scarce. The few existing data suggest that only 13% to 54% of HIV-infected persons identified through HBHCT enter pre-ART care. No studies have rigorously evaluated interventions aimed at improving linkage to pre-ART care following HBHCT in SSA. This study will evaluate the effect of follow-up counselling after HIV diagnosis through HBHCT on linkage to pre-ART care in Masaka, south-western Uganda.
The study is a cluster randomised trial of the effectiveness of referral to pre-ART care and follow-up counselling (intervention) compared to referral to pre-ART care only (control), for individuals diagnosed with HIV through HBHCT. The intervention will be administered at months 1 and 2, and linkage to care assessed at month 6 post-HBHCT. Data will be collected on socio-demographic characteristics, sexual risk profile, HIV testing history, HIV status disclosure, linkage to care, CD4 count testing and results, cotrimoxazole prophylaxis, and ART initiation. At least 224 HIV-infected participants will be enrolled from 28 clusters (14/study arm). Approximately 84 HIV-uninfected individuals will also be recruited into the study to reduce the possibility of revealing the sero-status of the HIV-infected participants.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow-up counselling | Experimental | Behavioral: Follow-up counsellingParticipants in the experimental arm will receive home-based HIV counselling and testing and referral for HIV care if found to have HIV infection. Additionally, participants will receive home-based follow-up counselling at 1 and 2 months after HIV diagnosis. |
| Standard of care | No intervention | –Participants in this arm will receive only home-based HIV counselling and testing and referral for HIV care if found to have HIV infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV-infected adult (≥18 years)
- Willing to provide informed consent
- Willing to receive follow-up counselling at home
- HIV negative adult (≥18 years)
- Willing to provide informed consent
Key exclusion criteria (7 listed)
- Previous or current receipt of HIV care from an ART provider
- On-going participation in other health-related research
- Intending to change residence in the next 6 months
- Conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness
- HIV-uninfected participants
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 |
|---|---|---|
| Follow-up counselling | Behavioural | Follow-up counselling |
Primary outcome
The proportion of HIV-infected participants that register with an anti-retroviral therapy (ART) care provider within 3 and 6 months of HIV diagnosis and referral.
Time frame: 6 months
The time between HIV diagnosis and linkage to pre-ART care.
Time frame: 6 months
3 secondary outcomes
Time between blood draw for CD4 cell count testing and attending clinic to receive the results among participants that link to pre-ART care
Time frame: 6 months
The time between learning that a participant is eligible for ART and ART initiation
Time frame: 6 months
The proportion of participants who report adherence to daily cotrimoxazole prophylaxis at 3 and 6 months after HIV diagnosis through HBHCT among those that link to pre-ART care.
Time frame: 6 months
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 23 Mar 2016.
- Derived from this study: PubMed 29052344Ruzagira E, Grosskurth H, Kamali A, Baisley K. Brief counselling after home-based HIV counselling and testing strongly increases linkage to care: a cluster-randomized trial in Uganda. J Int AIDS Soc. 2017 Oct;20(2):e25014. doi: 10.1002/jia2.25014.
- Individual participant dataSharing planned: No
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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.
Eugene Ruzagira principal investigator
MRC/UVRI and LSHTM Uganda Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up counselling in people with HIV, run by MRC/UVRI and LSHTM Uganda Research Unit 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 6 inclusion and 7 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 23 Mar 2016. 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?
The proportion of HIV-infected participants that register with an anti-retroviral therapy (ART) care provider within 3 and 6 months of HIV diagnosis and referral. (time frame: 6 months). 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 NCT02497456, 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 23 Mar 2016.