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Development of a program to monitor patients who were started on HIV treatment on the same day of HIV diagnosis

Developing a Standard Operating Procedure for monitoring same-day initiation of antiretroviral therapy among newly diagnosed persons living with HIV in South Africa

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN99248870
Enrollment
130
Registered
2025-04-03
Start date
2023-01-03
Completion date
Unknown
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improving adherence to HIV treatment among newly HIV-diagnosed patients Infections and Infestations

Interventions

Following the patients' written informed permission, the researcher conducted a screening evaluation to assess the study exclusion criteria. Eligible participants were then enrolled and randomly assig

Sponsors

South African Medical Research Council
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. All patients above 18 years are eligible for ART on the same day as HIV testing services (HTS) (same-day initiation) 2. Patients whose status is known but who have never been initiated on ART 3. Adolescents from 12 years after the completion of the HIV disclosure process in accompaniment of the parent or caregiver 4. Stable mental health patients deemed fit to be initiated on ART All patients whose permanent and temporary addresses are known and reachable for the duration of the study

Exclusion criteria

Exclusion criteria: 1. Symptomatic client who does not meet the criteria of same-day ART initiation 2. Active mental health condition 3. Clients below the age of 12 years 4. Antenatal clients enrolled in the prevention of mother-to-child transmission program 5. Known HIV-positive client who was once initiated on treatment and defaulted 6. TB co-infected client 7. A newly HIV-positive person who is likely to seek a transfer to unreachable locations during the study period.

Design outcomes

Primary

MeasureTime frame
Retention in care is defined as maintaining an HIV-1 RNA level <50 copies/ml 6 months following HIV testing. This outcome was measured at baseline and month 6 using the whole blood that would measure HIV-1 RNA level (viral load)

Secondary

MeasureTime frame
1. Retention in care with HIV-1 RNA <1,000 copies/mL at 6 months post-testing, which was also measured from baseline and at month 6 2. Adherence is measured using pharmacy refill records at months 1, 2, 3, 4, 5, and 6 3. Loss to follow-up measured using patient charts and phone calls at 6 months into treatment 4. Mortality rate was measured using phone calls to verify from the family members and the clinic file at months 1, 2, 3, 4, 5, and 6

Countries

South Africa

Contacts

Public ContactSiyakudumisa Nontamo
206607687@mywsu.ac.za+27 (0)712341138

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026