| Protocol No: | ECCT/17/08/07 | Date of Protocol: | 06-03-2017 |
| Study Title: | Impact of a novel HIV-1 RNA testing intervention to detect acute and prevalent HIV infection and reduce HIV transmission – Tambua Mapema Plus |
| Study Objectives: |
General Objective: To conduct a proof-of-concept study to test the efficacy of a health facility-based HIV-1 RNA testing intervention to identify acute (i.e., RNA-positive, seronegative or discordant rapid results) and prevalent (i.e., RNA-positive, seropositive) HIV infection.
Specific Objectives:
1. To identify and test 1,500 adults identified by our HIV-1 RNA testing intervention for acute and prevalent (i.e., seropositive) HIV, linking all newly diagnosed HIV-infected patients to care and offering immediate treatment.
2. To offer assisted partner notification services (aPS) to all cases detected in objective 1, testing partners for acute and prevalent HIV infection and identifying local sexual networks.
3. To model the potential impact of the HIV-1 RNA testing and aPS interventions on the Kenyan HIV epidemic, estimating incremental costs per HIV infection averted, death averted, and disability-adjusted life-year (DALY) averted using data on outcomes from our innovative program.
4. To conduct qualitative in-depth interviews with up to 60 newly diagnosed prevalent and AHI patients and seronegative partners in discordant relationships to gain insights into intervention uptake, including barriers and facilitators to ART or PrEP uptake and adherence in these groups.
5. To conduct interviews or focus groups with up to 60 individuals who work in the 6 health facilities where the trial will take place (up to 10 participants per facility), to obtain their views on the detection of acute HIV infection and the research carried out at the facility, including challenges to intervention scale-up.
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| Laymans Summary: |
What is the problem/background?
Patients who seek health care for symptoms are occasionally tested for prevalent HIV (i.e. positive on rapid antibody tests). A small proportion (~1%) of patients who test negative for prevalent HIV may actually have ‘acute HIV’ (i.e. positive on a special test, qualitative X-pert RNA test) as the cause of their symptoms. Patients with acute HIV infection (AHI) are very infectious and would benefit from early diagnosis and early treatment, and their partners would benefit from prompt notification and evaluation.
What questions are we trying to answer?
We will test whether a new AHI testing intervention will identify more HIV infections (both prevalent and acute HIV) compared to standard testing (provider-initiated testing and counselling, PITC for prevalent HIV) among patents aged 18-39 years seeking care for symptoms, and determine whether assisted partner notification and care navigation offered by HIV-1 RNA testing intervention staff will lead to more infections diagnosed among partners, more HIV-infected persons starting treatment, and more viral suppression among treated patients.
Where is the study taking place, how many people does it involve and how are they selected?
The study will take place at six health facilities (2-4 government and 2-4 private) in Kilifi and Mombasa County. A total of 2875 patients seeking care and up to 300 partners of HIV-infected patients will be enrolled. Patients eligible for participation will be invited to participate upon urgent care seeking.
What does the study involve for those who are in it?
Participants will either be observed (PITC, comparison group) or undergo AHI testing intervention (both prevalent and AHI testing, intervention group). All participants will undergo a brief questionnaire about symptoms and sexual risk behavior. Participants who are diagnosed with acute or prevalent HIV infection will be asked about partners, who will be a contacted by research staff for HIV evaluation. All participants and partners diagnosed with HIV infection will be offered immediate treatment, and HIV-negative partners whose partner is HIV-infected will be offered pre-exposure prophylaxis (PrEP) for the duration of 6 months, or until viral suppression is achieved by the HIV-infected partner.
What are the benefits and risks/costs of the study for those involved?
Benefits include learning about research, obtaining accurate HIV status, immediate treatment when infected, and protecting one’s partner. There is some risk of loss of privacy or confidentiality.
How will the study benefit society?
Results of this study will be directly applicable to implementation of HIV-1 RNA testing intervention for acute and prevalent HIV infection among young adults in resource-limited settings. In addition, the diagnosis and immediate treatment of persons with acute and previously undiagnosed prevalent HIV infection will reduce HIV transmission risk.
When does the study start and finish?
The study will start in November 2017 and will continue for 4 years.
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| Abstract of Study: |
Our study will assess the impact of an intervention consisting of a consensus acute HIV infection risk score algorithm for acute and prevalent (i.e., seropositive) HIV testing among 1,500 adult patients aged 18-39 years who seek urgent care for symptoms at primary care facilities. We will link all newly diagnosed HIV-infected patients to care, offer immediate treatment, and offer assisted partner notification, evaluation for prevalent or acute HIV infection, and either antiretroviral therapy (if HIV-infected) or pre-exposure prophylaxis (if uninfected with a serodiscordant, HIV-positive partner). We will also model the potential impact of the AHI testing and assisted partner notification interventions on the Kenyan HIV epidemic, estimating incremental costs per HIV infection averted, death averted, and disability-adjusted life-year (DALY) averted using data on outcomes from our innovative program.
We will use a modified stepped wedge design to evaluate the yield of the AHI testing intervention at 2-4 public and 2-4 private health facilities in Kenya, before (1,375 patients) and after (1,500 patients) intervention delivery. We expect to diagnose over two-fold more HIV infections through this intervention than are currently diagnosed through provider-initiated testing and counselling. Assisted partner notification should identify at least two-fold more previously undiagnosed individuals for each index case identified than passive referral strategies (the current standard of care), augmenting intervention impact. Through modelling, we will estimate the impact of this combined intervention on HIV transmission and evaluate the potential cost-effectiveness of such an approach under a wide range of estimations. We expect this work to provide invaluable data that will help improve HIV testing and treatment as prevention in sSA.
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