Intensive combination approach to rollback the HIV epidemic in Nigerian adolescents
| ISRCTN | ISRCTN94590823 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94590823 |
| Secondary identifying numbers | STU00207490 |
- Submission date
- 11/05/2021
- Registration date
- 12/05/2021
- Last edited
- 31/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Youth, particularly young men who have sex with men, are weak links in Nigeria’s response to the HIV epidemic. While there are many complicated factors that fuel the epidemic in these groups, a void of evidence-based interventions is remediable and necessary to advance the UNAIDS 90-90-90 goals. Therefore, we will investigate a novel youth-specific approach that includes peer navigation and mHealth components and has been locally adapted using focus groups and stakeholder consultations.
The HIV testing and linkage pilot study will reach at-risk youth through social media and in-person outreach conducted by peer navigators, who will be trained to implement the manualized combination intervention, focused on promoting HIV testing and linkage to care.
Who can participate?
The study will evaluate the number and results of HIV tests of young men ages 15 - 24 years residing in Ibadan city and surrounding areas.
What does the study involve?
HIV tests taken before (24 weeks) and during the intervention period (48 weeks), will be abstracted from surveillance records for analysis.
What are the possible benefits and risks of participating?
There may be no benefit of participation in this study, however, participants may enjoy the opportunity to interact with the peer navigator. The primary risks are breach of confidentiality.
Where is the study run from?
University of Ibadan (Nigeria)
When is the study starting and how long is it expected to run for?
November 2017 to May 2020
Who is funding the study?
The study is funded by the National Institutes of Health in the United States of America.
Who is the main contact?
Dr Robert Garofalo, rgarofalo@luriechildrens.org
Contact information
Scientific
225 E. Chicago Ave
Box 161
Chicago
60611
United States of America
 ORCID ID |
0000-0001-9513-9416 |
|---|---|
| Phone | +1 312-227-6800 |
| rgarofalo@luriechildrens.org |
Study information
| Study design | Quasi-experimental pre-post design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Intensive Combination Approach to Rollback the Epidemic in Nigerian adolescents: UG3 phase, HIV testing arm |
| Study acronym | iCARE |
| Study objectives | 1. HIV Testing Hypothesis: The number of male youths who undergo HIV testing through the study site will be greater in the 48-weeks after the introduction of the intervention (in 24-week intervals) compared to 24 weeks before initiating the intervention. 2. Seroincidence Hypothesis: The number of confirmed HIV positive cases divided by total number of tests (i.e., seroincidence) will be greater in the 48 weeks post intervention compared to post intervention (in 24-week intervals). |
| Ethics approval(s) | Approved 10/05/2018, Northwestern University IRB (750 N. Lakeshore Drive, 7th FL, Chicago, IL 60611, USA; +1-312-503-9338; irb@northwestern.edu), ref: STU00207490 |
| Health condition(s) or problem(s) studied | HIV screening and prevention |
| Intervention | We promoted HIV prevention education and community-based HIV testing through social media platforms and navigated interested young men to HIV testing in clinic or community locations. Among young men who engaged in HIV testing visits, data on their demographics, testing history, HIV test result, and satisfaction with the testing visit were collected via anonymous survey and abstracted from testing surveillance records. Individuals with a preliminary positive test result were navigated to HIV care at a clinical location of their choice. Consent for data collection was provided via a consent statement with a waiver of documentation of consent, to maintain anonymity. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Number of male youth who undergo HIV testing through the study site (i.e. tested on site or by a peer navigator in the community) measured using completed HIV tests abstracted from HIV surveillance forms at the point of HIV testing and immediately thereafter 2. The HIV seroincidence of this group, calculated as the number of confirmed HIV cases divided by the total number of tests measured using HIV test results abstracted from HIV surveillance forms at the point of HIV testing and immediately thereafter |
| Secondary outcome measures | 1. The proportion of newly diagnosed youth who are linked to care for antiretroviral therapy measured using linkage to HIV care abstracted from HIV surveillance forms at the point of HIV testing and immediately thereafter 2. Feasibility, acceptability, and satisfaction with the intervention measured using the Client Satisfaction Questionnaire (CSQ-8) at the point of HIV testing |
| Overall study start date | 01/11/2017 |
| Completion date | 31/05/2020 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Mixed |
| Sex | Male |
| Target number of participants | 339 |
| Total final enrolment | 339 |
| Key inclusion criteria | HIV tests of young men ages 15 - 24 years residing in Ibadan city, Nigeria and surrounding areas before (24 weeks) and during the intervention period (48 weeks) will be abstract from surveillance records of the Infectious Disease Institute of the University of Ibadan, College of Medicine for analysis. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/06/2019 |
| Date of final enrolment | 31/05/2020 |
Locations
Countries of recruitment
- Nigeria
Study participating centre
College of Medicine
P.M.B 3017 G.P.O
Oyo State
Ibadan
P.M.B 3017 G.P.O
Nigeria
Sponsor information
Government
9000 Rockville Pike
Bethesda
20892
United States of America
| Phone | +1 301-496-4000 |
|---|---|
| nichdpress@mail.nih.gov | |
| Website | http://www.nih.gov/ |
"ROR" |
https://ror.org/01cwqze88 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Institutos Nacionales de la Salud, US National Institutes of Health, NIH
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this study will be published in peer reviewed manuscripts. |
| IPD sharing plan | The de-identified data from the study trial are available from the study investigators by request (rgarofalo@luriechildrens.org) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/02/2022 | 23/02/2022 | Yes | No | |
| Other publications | Qualitative results | 30/10/2023 | 31/10/2023 | Yes | No |
Editorial Notes
31/10/2023: Publication reference added.
23/02/2022: Publication reference added.
13/12/2021: The intention to publish date was changed from 01/06/2021 to 01/03/2022.
01/06/2021: Uploaded protocol version 1.0, 22 March 2019 (not peer reviewed).
12/05/2021: Trial's existence confirmed by Northwestern University.
