The Effectiveness of a Counselling Intervention on the Uptake of HIV Care Services Among HIV Infected Patients in Uganda
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Masaka, Uganda
- MRC/UVRI Uganda Research Unit on AIDS
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
HIV-infected participants
Inclusion Criteria:
- HIV-infected adult (≥18 years)
- Willing to provide informed consent
- Willing to receive follow-up counselling at home
Exclusion Criteria:
- 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
Inclusion criteria:
- HIV negative adult (≥18 years)
- Willing to provide informed consent
- Willing to receive follow-up counselling at home
Exclusion criteria:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Follow-up counselling
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.
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Inget ingripande: Standard of care
Participants in this arm will receive only home-based HIV counselling and testing and referral for HIV care if found to have HIV infection.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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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.
Tidsram: 6 months
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6 months
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The time between HIV diagnosis and linkage to pre-ART care.
Tidsram: 6 months
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6 months
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Sekundära resultatmått
Resultatmått |
Tidsram |
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Time between blood draw for CD4 cell count testing and attending clinic to receive the results among participants that link to pre-ART care
Tidsram: 6 months
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6 months
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The time between learning that a participant is eligible for ART and ART initiation
Tidsram: 6 months
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6 months
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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.
Tidsram: 6 months
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6 months
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Andra resultatmått
Resultatmått |
Tidsram |
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The proportion of individuals who undergo repeat HIV testing within 6 months of testing HIV negative through HBHCT.
Tidsram: 6 months
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6 months
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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Eugene Ruzagira, MRC/UVRI and LSHTM Uganda Research Unit
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- Linkage to pre-ART care
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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