Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202008859669317 Date of Registration: 14/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Tambua Mapema Plus
Official scientific title Impact of a novel HIV-1 RNA testing intervention to detect acute and prevalent HIV infection and reduce HIV transmission
Brief summary describing the background and objectives of the trial This is a proof-of-concept study comparing outcomes of a health facility-based acute HIV infection (AHI) and prevalent HIV testing intervention using point of care HIV-1 RNA detection, combined with assisted partner services (aPS) and follow-up in an antiretroviral therapy (ART) cohort for all newly diagnosed individuals and follow-up in a pre-exposure prophylaxis (PrEP) cohort for the uninfected partners of newly diagnosed individuals, compared to standard care.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TMP
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/12/2017
Actual trial start date 01/12/2017
Anticipated date of last follow up 15/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 3175
Actual target sample size (number of participants) 2881
Recruitment status Closed to recruitment,follow-up continuing
Publication URL https://www.researchprotocols.org/2020/8/e16198/
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group HIV testing per Kenyan guidelines and clinician judgment Rapid antibody testing as per national testing guidelines N/A The first phase is the observation period in which all testing and treatment will be per Kenyan Ministry of Health guidelines and primary care clinician judgment. Adults seeking care at primary health care clinics who have never been diagnosed with HIV and have a risk score of 2 or higher will be offered participation. HIV testing will only be done if ordered by the primary care clinician. Research procedures in the observation period will consist of a computer-assisted self interview (CASI) at baseline (all participants) assessing sexual risk behaviour, and a home visit at 6 weeks (only for those diagnosed with HIV at baseline). The 6-week visit will include a second CASI and follow-up on uptake of care and treatment and partner notification. Those who have not yet notified partners will be offered assisted partner notification with standard HIV testing (i.e., standard aPS). Participants found to be HIV negative and those not tested will end their participation at the baseline visit. Those diagnosed HIV positive will have 2 visits, baseline and 6 weeks. 1374 Uncontrolled
Experimental Group HIV 1 RNA testing intervention HIV1 RNA testing followed by rapid tests if RNA positive N/A In the intervention period, there are four major interventions being tested: testing for acute and prevalent HIV infection, aPS using our HIV-1 RNA testing intervention (i.e., enhanced aPS), an ART cohort at KEMRI, and a PrEP cohort at KEMRI. Adults seeking care at primary care clinics with no history of HIV and a risk score of 2 or more will be offered enrollment. In the intervention phase, all participants will undergo HIV testing consisting of testing for HIV-1 RNA initially, followed (if positive) by testing with 2 rapid HIV tests per Kenyan HIV testing guidelines. Those who test negative end participation at the baseline visit after the CASI. Those who test positive (either AHI or prevalent case) are offered enhanced aPS and participation in the ART cohort at KEMRI and can accept or decline each one. Those who decline follow-up at KEMRI will end their participation at the 6-week visit (as described for the observation period), those who accept will be followed at KEMRI for 12 months. Those who test positive will also be offered participation in qualitative interviews, which they may accept or decline without influencing other components 1500
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• age from 18-39 years; • not previously diagnosed with HIV infection; and • a score ≥2 on our risk score algorithm to identify persons at higher risk for AHI, with scoring as follows: o age 18-29 years (1), o fever (1), o fatigue (1), o body pains (1), o diarrhea (1), o sore throat (1), and o GUD (3). Eligibility criteria for partners of newly diagnosed cases with prevalent or acute HIV include: • age over 18 years; and • not previously diagnosed HIV infection. Patients not meeting inclusion criteria or those who are not willing or able to participate (e.g., due to illness or time constraints, or at the discretion of the study clinician) will be excluded. Individuals at high risk for IPV are excluded from the aPS intervention, but eligible for all other components of the study. Adult: 19 Year-44 Year 18 Year(s) 39 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/07/2016 KEMRI SCIENTIFIC ETHICS REVIEW UNIT
Ethics Committee Address
Street address City Postal code Country
P O Box 54840 Nairobi 00200 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/06/2017 Oxford Tropical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Oxford Research Services, University Offices Wellington Square, Oxford, OX1 2JD Oxford 0000 United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/06/2017 University of Washington Human Subjects Division
Ethics Committee Address
Street address City Postal code Country
4333 Brooklyn Ave. NE, Box 359470 Seattle, WA 98195-9470 Washington 9470 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To conduct a proof-of-concept study to determine outcomes of a health facility-based HIV-1 RNA testing intervention to identify acute (i.e., RNA-positive, seronegative or discordant rapid test results) and prevalent (i.e., RNA-positive, seropositive) HIV infection, compared to standard care. Baseline and at week 6
Secondary Outcome Linkage to care: To determine the feasibility, acceptability, and uptake of offering immediate linkage and treatment to all newly diagnosed HIV-infected patients in the intervention period, comparing this approach to standard care. Baseline and at week 6
Secondary Outcome Partner testing: To determine the feasibility, acceptability, and uptake of aPS for partner identification and testing, comparing enhanced aPS with HIV-1 RNA testing in the intervention period to passive referral followed by delayed aPS with standard HIV testing in the observation period. Baseline and at week 6
Secondary Outcome Impact and cost-effectiveness: To model the potential impact of the HIV-1 RNA testing, linkage, immediate treatment, and aPS interventions on the Kenyan HIV epidemic, in terms of incremental costs per HIV infection averted, death averted, and disability-adjusted life-year (DALY) averted, using data on standard care outcomes from the observation period and data on intervention outcomes from the intervention period. Baseline and at week 6
Secondary Outcome Barriers and facilitators: 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. at week 2, month 3, 6, 9 and 12
Secondary Outcome Staff views: 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 HIV-1 RNA testing and the research carried out at the facility, including challenges to intervention scale-up. At the end of the observation phase and intervention phase at each facility
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenya Medical Research Institute Centre for Geographic Medicine Research Coast CGMRC Off Hospital Rd, P O Box 230 KILIFI 80108 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institutes of Health NIH 9000 Rockville Pike, Bethesda, Maryland Maryland 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Division of AIDS DAIDS National Institute of Allergy and Infectious Diseases NIAID National Institutes of Health NIH 9000 Rockville Pike, Bethesda Maryland 20892 United States of America Government body
COLLABORATORS
Name Street address City Postal code Country
University of Oxford Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, New Richards Building, Old Road Campus, Roosevelt Drive, Oxford, OX3 7LG Oxford 0000 United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eduard Sanders ESanders@kemri-wellcome.org +254723593762 KEMRI Wellcome Trust Research Programme, Off Hospital Road, Box 230
City Postal code Country Position/Affiliation
Kilifi 80108 Kenya Principal Investigator Key Populations Studies Cluster
Role Name Email Phone Street address
Scientific Enquiries Susan Graham grahamsm@uw.edu +0012062218435 University of Washington Box 359909, 325 Ninth Avenue, Seattle, WA 98104
City Postal code Country Position/Affiliation
Washington 98104 United States of America Principal Investigator University of Washington Associate Professor Global Health and Medicine
Role Name Email Phone Street address
Public Enquiries Clara Agutu CAgutu@kemri-wellcome.org +254720735000 KEMRI Wellcome Trust Research Programme, Off Hospital Rd, Box 230
City Postal code Country Position/Affiliation
Kilifi 80108 Kenya Project Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes After the study period, once the primary results are published, a de-identified copy of the data will be prepared for deposition in the KWTRP data repository (https://dataverse.harvard.edu/) under managed access through the KWTRP Data Governance Committee (Data_Governance_Committee@kemri-wellcome.org). We will make every effort to prevent re-identification of subjects by coding data that has the potential of being identifiable. Informed Consent Form,Study Protocol Following publication of the main study results Access will be managed through the KWTRP Data Governance Committee (Data_Governance_Committee@kemri-wellcome.org).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information