Development of a program to monitor patients who were started on HIV treatment on the same day of HIV diagnosis
| ISRCTN | ISRCTN99248870 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99248870 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | South African Medical Research Council |
| Funders | Chemical Industries Education and Training Authority (CHIETA) , Strategic Health Innovation Partnerships (SHIP) of the Medical Research Council (MRC) |
- Submission date
- 22/01/2025
- Registration date
- 03/04/2025
- Last edited
- 03/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
The South African government wants to improve HIV treatment and achieve global targets. One way to do this is by starting patients on antiretroviral therapy (ART) on the same day they're diagnosed with HIV. This approach is called same-day initiation (SDI). Research shows that starting ART early reduces illness, death, and the spread of HIV. It also boosts patients' hope and optimism. However, putting SDI into practice is challenging due to various obstacles. Some of the challenges include structural barriers such as healthcare system issues, like laboratory result delays; attitudes such as patients' and healthcare providers' attitudes toward SDI; and additional challenges in developing countries such as substance abuse, housing instability, and managing clinical symptoms. Although South Africa has adopted SDI, there are concerns about whether patients stay in treatment and how effective the treatment is. This study aims to create a comprehensive plan (standard operating procedure) to:
1. Monitor how well SDI is implemented.
2. Measure the outcomes of treatment.
By doing so, the study hopes to improve the effectiveness of SDI in South Africa.
Who can participate?
All newly diagnosed people aged 12 years and over living with HIV
What does the study involve?
Participants are randomly allocated to one of two groups, namely the intervention group and the control group. The intervention group would receive the interventions aimed at improving treatment outcomes, while the control group would use the normal protocol which does not involve new interventions. Lastly, this study involves the collection of blood, home visits, and social worker involvement among patients in the intervention group.
What are the possible benefits and risks of participating?
The participants may benefit directly from this study due to improved treatment outcomes (adherence, viral load suppression and prevention of HIV-related deaths). Secondly, patients have an opportunity to see a social worker, assigned to a treatment advisor, and have their treatment delivered to their homes. There are no risks in participating in this study.
Where is the study run from?
This study was run in the O.R. Tambo district, Eastern Cape, South Africa. The study was conducted at three healthcare clinics, namely, Mthatha Gateway Clinic, Tsolo Clinic, and Flagstaff Clinic.
When is the study starting and how long is it expected to run for?
The study was conducted (begin data collection) from 09 January 2023 to 16 August 2023. This study was expected and ran for six months. However, the study plan was proposed on 06/08/2021.
Who is funding the study?
This study was supported by the Chemical Industries Education and Training Authority (CHIETA) and the Strategic Health Innovation Partnerships (SHIP) of the Medical Research Council (MRC), funding attributed to Prof. Eugene Jamot Ndebia.
Who is the main contact?
For the study: Siyakudumisa Nontamo, siyakudumisanontamo86@gmail.com and 206607687@mywsu.ac.za
For funding: Professor Eugen Ndebia endebia@wsu.ac.za
Contact information
Public, Scientific, Principal investigator
03 Swift Street
Southernwood
Mthatha
5099
South Africa
 ORCID ID |
0009-0001-6929-0275 |
|---|---|
| Phone | +27 (0)712341138 |
| 206607687@mywsu.ac.za |
Scientific
Private Bag X1
Walter Sisulu University
Mthatha
5099
South Africa
| ORCID ID |
0000-0002-5840-0715 |
|---|---|
| Phone | +27 (0)767550574 |
| siyakudumisanontamo86@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter interventional unblinded randomized controlled trials |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Developing a Standard Operating Procedure for monitoring same-day initiation of antiretroviral therapy among newly diagnosed persons living with HIV in South Africa |
| Study objectives | By and large, when carefully measured and monitored, same-day antiretroviral therapy (ART) initiation improves treatment adherence, retention to care, and viral load suppression. A procedure to measure and monitor same-day ART initiation will be associated with positive treatment outcomes. As a result, if developed and implemented, positive treatment outcomes will flourish even further in South Africa. Therefore, the HIV care continuum will be optimized, and the 959595 UNAIDS strategy will be achieved by 2024. Subsequently, the Millennium Development Goal (MDG) that aims to achieve an ambition of free HIV generation’ by 2030 is to be achieved, and life expectancy will further improve. |
| Ethics approval(s) |
Approved 28/09/2022, Walter Sisulu University Faculty of Health Sciences Research Ethics and Biosafety Committee (Walter Sisulu University, NMD Campus, Private Bag X1, Mthatha, 5099, South Africa; +27 (0)475022100; fhs@wsu.ac.za), ref: 027/2022 |
| Health condition(s) or problem(s) studied | Improving adherence to HIV treatment among newly HIV-diagnosed patients |
| Intervention | 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 assigned on the same day of HIV testing. A computer-generated random-number list was used to randomly assign participants to either standard ART or same-day ART initiation in a 1:1 ratio, with allocation concealment. Participants were enrolled and divided into study groups by the researcher. However, participants, site personnel, and the study supervisor were not blinded to the group assignments. After randomization: 1. Standard group: Received ART initiation as per national guidelines, with follow-up on Day 28 2. Intervention group: Received additional support, including: 2.1. Assignment to patient navigator after starting treatment 2.2. Day 5: Nurse support (blood result interpretation, side effect management, counseling) 2.3. Day 14: Social worker support (counseling, disclosure support, needs assessment, opportunistic infection evaluation) The duration of the interventions was 6 months from the date the participant was enrolled in the study. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
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) |
| Key secondary outcome measure(s) |
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 |
| Completion date | 16/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 12 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 130 |
| Total final enrolment | 142 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 03/01/2023 |
| Date of final enrolment | 17/02/2023 |
Locations
Countries of recruitment
- South Africa
Study participating centres
Mthatha
5099
South Africa
Flagstaff
4810
South Africa
71 Nelson Mandela Drive
Mthatha
5099
South Africa
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Siyakudumisa Nontamo (siyakudumisanontamo86@gmail.com) and Professor Eugene Ndebia (endebia@wsu.ac.za) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/01/2025: Study's existence confirmed by Walter Sisulu University Faculty of Health Sciences Research Ethics and Biosafety Committee.
