Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 89647 for:    testing

Innovative Tools to Expand HIV Self-Testing (I-TEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04070287
Recruitment Status : Enrolling by invitation
First Posted : August 27, 2019
Last Update Posted : August 27, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Nigerian Institute of Medical Research
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Juliet Iwelunmor, PhD, St. Louis University

Brief Summary:

The I-TEST study builds upon two participatory approaches, open challenge contests and entrepreneurship training. The study utilizes open challenge contest to generate youth-driven interventions on strategies to promote HIV self-testing and other testing for other sexually transmitted infections (STIs) among young people in Nigeria. Open challenge contests involves leveraging on the knowledge and strengths of the crowd (in this case young people) to generate solutions to an issue. Following completion of one of the open challenge contest, was the Designathon contest where young people in Nigeria collaborated to develop new services and products for promoting self-testing for HIV and other sexually transmitted diseases, guided by human-centered, design thinking framework. After which, six teams from the Designathon were selected to move onto an Innovation bootcamp. The Innovation bootcamp was a 4-week long accelerated training program for young people to delve into the world of entrepreneurial and innovation management skills, while applying basic research principles. At the end of the course, 5 finalist teams were selected to pilot test their innovation plan in the community for a duration of 6 months, beginning July 2019.

This study is focused on evaluating the effectiveness of these five youth participatory interventions on HIV testing and other key prevention among at risk youth (14-24 years old in Nigeria).This research study will involve undertaking a prospective one-year assessment of these five pilot interventions.


Condition or disease Intervention/treatment Phase
HIV/AIDS Sexually Transmitted Diseases Combination Product: SMART Pack Combination Product: Luv Box Combination Product: Bili Vibes Combination Product: BeterDoc Combination Product: IUNGO Early Phase 1

Detailed Description:

Step 1: Participant enrollment. This will involve recruiting youth to participate in the pilot study. Participant recruitment strategies will include: social media, online, event- and venue based, participant referral, and walk-ins at study clinics. Participant enrollment will be completed by study team.

Step 2: Intervention implementation. Following participant recruitment and enrollment in the study. Study participants will be assigned to one of the 5 youth participatory interventions focused on expanding the uptake of HIV self-testing and key HIV prevention services. The pilot intervention implementation would occur for 6 months. Nigerian Institute of Medical Research (NMIR) will provide local training on HIV prevention to the five participatory interventions following their existing guidelines.The participatory interventions will be conducted in the locations of the five teams who emerged as winners from the innovation boot-camp. These participatory interventions will only provide HIV self-testing kits and instructions of how to perform the test to participants. They will also provide referral coupons to youth friendly centers for sexually transmitted infections (STI) screening and treatment and pre-exposure prophylaxis (PrEP) awareness and initiation for at-risk youth. The referral coupons are intended to provide study participants information on trained youth friendly centers that are involved with the research. The referral coupons give the study participants access to other sexually transmitted infections (STI) screening and treatment and pre-exposure prophylaxis (PrEP) awareness and initiation at these health facilities. The intervention only provide participants with the HIV self-testing kits and then refer them to youth-friendly health facilities for other testing services. The intervention does not involve monitoring HIV self-testing procedure, the investigators will only be asking for self-reported HIV testing and other sexually transmitted diseases testing.

Step 3: Baseline data collection. After allocation of participants into the intervention, study team will collect baseline data on HIV testing history, sexual behavior history, youth participation experience, and other related outcomes will be collected (survey questionnaire attached) from recruited participants. Participants mobile phone numbers will also be collected as tracking information for follow-up and retention in a coupon format. The mobile phone numbers would be used to contact study participants through text messages and phone calls. These contacts would serve as reminders for participants to participate in follow-up data collection. The mobile phone service charge would be covered by the research. No other personal identifiers will be collected and no biological specimens will be collected at baseline. The investigators will obtain informed consent before proceeding with any data collection.

Step 4:Health facilities training. For the purposes of this research study, the Nigerian Institute of Medical Research team would provide training to youth-friendly health centers currently working with the Nigerian Institute of Medical Research based on the World Health Organization guidebook for youth-friendly health services (handbook is attached).The training would be to ensure that these health facilities are trained to provide youth friendly services to participants who be referred to receive STI screening, STI treatment and PrEP awareness and initiation. Following the training, the NIMR research team would in charge of collecting data to record record participants HIV self-testing uptake as well as uptake of STI screening, STI treatment and PrEP awareness and initiation.

Step 5: Follow up surveys at 3 and 6 months: At 3 and 6 months post intervention implementation, study team will collect similar baseline data from study participants. The follow-up survey will assess HIV testing, sexual behavior history, youth participation experience and other related outcomes will be collected (survey questionnaire attached) from recruited participants.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Intervention Pilot

This study protocol will involve undertaking a prospective one-year assessment of five youth participatory interventions. These interventions are focused on promoting HIV self-testing and referrals to health facilities for other sexually transmitted infections test.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Innovative Tools to Expand HIV Self-Testing
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: SMART Pack
This involves using "SMART Pack" a HIV self-testing kit to promote uptake of HIV self-testing among young people at community centers.
Combination Product: SMART Pack
The SMART pack is a re-branded and repackaged box for HIV self-testing kits. The intervention aims to promote distribution of HIVST kits through in institutions, vocational centers, and social media platforms. The intervention would also include a referral systems, where participants provided with the HIV self-testing kits are provided with information with youth-friendly health facilities for uptake of testing for sexually transmitted infections. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the SMART pack and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Yaba local government area in Lagos state.
Other Name: The OraQuick®ADVANCERapid HIV-1/2 Antibody Test

Active Comparator: Luv Box
The intervention involves using "Luv Box" a box that include personal hygiene products and HIV self-testing kit as strategy to promote uptake of HIV testing among young people.
Combination Product: Luv Box
The Luv box is packaged in two colors: blue and pink. The LUVBox would be made available in supermarkets, on-line stores, mini-marts, pharmacies, neighborhood stores and markets, for easy accessibility in hard to reach areas. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "Luv Box" and the location where the pack can be obtained for individuals who are interested.For this pilot study, the intervention will be implemented in Yaba in Lagos state.
Other Name: The OraQuick®ADVANCERapid HIV-1/2 Antibody Test

Active Comparator: Bili Vibes
The intervention involves using a program program called "Bili" that leverages community youth events such as football matches as a strategy to promote the uptake of HIV self-testing among young people.
Combination Product: Bili Vibes
The HIV self-testing kits will be available for interested individuals at the community youth events. These events and information the HIV self-testing kits will be on flyers that would be promoted at community centers and schools. For this pilot study, the intervention will be implemented in Ngenevu/Bunker communities in Enugu state.
Other Name: The OraQuick®ADVANCERapid HIV-1/2 Antibody Test

Active Comparator: BeterDoc
This intervention involve using "BeterDoc Safety kits" that includes HIV self-testing kit, location and phone number to the health centers in the community as a strategy to promote update of HIV self-testing among young people.
Combination Product: BeterDoc
The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "BeterDoc Safety Kits" and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Ibadan, Dugbe and Agbowo in Oyo state.
Other Name: The OraQuick®ADVANCERapid HIV-1/2 Antibody Test

Active Comparator: IUNGO
This intervention involves using a program utilizes community vocational skills training centers to promote uptake of HIV self-testing among young people.
Combination Product: IUNGO
The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the HIV self-testing kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Akure South, Orita-Obele, Ipinsa, Ilara Mokin and Ijare in Ondo state.
Other Name: The OraQuick®ADVANCERapid HIV-1/2 Antibody Test




Primary Outcome Measures :
  1. Uptake of HIV testing over the 3 months follow-up [ Time Frame: 3 months following the first encounter ]
    The primary outcome will be assessed based on the proportion of participants who tested for HIV during the 3-month follow-up period. HIV testing will be self-reported and facility-based recording. This data will be collected through a structured questionnaire. In addition, participants will be asked to present at select youth friendly clinics, and are given the option to return the anonymized used HIVST kit or referral coupon in order to track test results.


Secondary Outcome Measures :
  1. Uptake of HIV testing over the 6 months follow-up [ Time Frame: 6-month ]
    This will be assessed based on the proportion of participants who tested for HIV during the 6-month follow-up period. HIV testing will be self-reported and facility-based recording. This data will be collected through a structured questionnaire. In addition, participants will be asked to present at select youth friendly clinics, and are given the option to return the anonymized used HIVST kit or referral coupon in order to track test results.

  2. Sexually Transmitted Infection (STI) Testing [ Time Frame: 6-month ]
    Proportion of participant who present at select youth friendly clinics for STI testing. In addition, the baseline and follow-up surveys include items on knowledge and testing of sexually transmitted infections (gonorrhea, chlamydia, syphilis and Hepatitis).

  3. Sexually Transmitted Infection (STI) Treatment [ Time Frame: 6-month ]
    STI treatment will be assessed based on the the number of participants who received treatment for STI (gonorrhea, chlamydia, syphilis and Hepatitis) over a 6-month follow-up period.

  4. PrEP Initiation [ Time Frame: 6-month ]
    The baseline and follow-up survey includes items on awareness, willingness and usage of pre-exposure prophylaxis. Questions about PrEP were preceded by a short plain-language statement describing it as: "There is a new prescription medication that people who are HIV-negative can take to lower their risk of getting HIV. It is sometimes referred to as pre-exposure prophylaxis or PrEP or by the brand name Truvada". In addition, PreP initiation will be assessed based on proportion of participants who are "optimal" (assessed based on the sexual behavioral history and willingness to use PrEP) candidates for PrEP initiation and the total number of participants referred for PrEP initiation at the health care facilities.

  5. 100% Condom Use [ Time Frame: 6-month ]
    The baseline and follow-up survey includes items on condom usage over the last 6 months and a 4-item Condom Use Self Efficacy Scale. The scale response options ranged from 0 " No", 1 "probably no", 2 "probably yes", to 4 "yes". The 4-item scale was constructed in part from a previously validated 14-item scale of condom self-efficacy.

  6. Youth Participation and Engagement [ Time Frame: 6-month ]
    The purpose of this measure is assess the extent to which young people in Nigeria can be prime movers in developing, implementing, and evaluating HIV preventive services. A 12-item scale on youth participation and engagement will be used to assess the HIV prevention services proposed by the youth teams. The scale was adapted from the 20-item Tiffany-Eckenrode Program Participation Scale (TEPPS). Responses to the participation items were measured on a 5-point Likert-type scale, ranging from "strongly disagree (0)" to "Strongly agree (4)". Higher TEPPS scores indicate higher levels of program participation. The item is only included in the follow-up survey.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 14-24
  2. Self-reported HIV negative or unknown HIV status
  3. Current resident of Lagos, Ondo, Oyo, and Enugu with plans to stay in city for the next 6 months
  4. Able to complete survey in English (the national language of Nigeria)
  5. All participants must agree to an informed consent and provide their cell mobile number for follow-up and retention

Exclusion Criteria:

  1. Younger than 14 and older than 24
  2. Inability to comply with study protocol
  3. Illness, cognitive impairment or threatening behavior with acute risk to self or others
  4. No informed consent
  5. No contact phone number
  6. Do not reside in Lagos, Ondo, Oyo, and Enugu

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04070287


Locations
Layout table for location information
Nigeria
Nigerian Institute of Medical Research
Yaba, Lagos, Nigeria, 00000
Sponsors and Collaborators
St. Louis University
National Institutes of Health (NIH)
Nigerian Institute of Medical Research
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Juliet Iwelunmor, PhD St. Louis University
Principal Investigator: Joseph Tucker, MD University of North Carolina, Chapel Hill
Principal Investigator: Oliver Ezechi, MD Nigerian Institute of Medical Research

Publications:
Nigeria Framework. National HIV and AIDS Strategic Framework. 2017-2021.
NACA. Federal Republic of Nigeria, Global AIDS Report: Country Progress Report. 2015. Accessed Novembner, 2015.
NDHS. National Population Commision; Nigerian Demographic and Health Survey Reports. 2013.
WHO. HIV Testing Services: WHO recommends HIV Self-testing. Geneva2016.
Ozer EJ, Piatt AA, Holsen I, Larsen T, Lester J, Ozer EM. INNOVATIVE APPROACHES TO PROMOTING POSITIVE YOUTH DEVELOPMENT IN DIVERSE CONTEXTS. Positive Youth Development in Global Contexts of Social and Economic Change. 2016:12.
Ozer EJ. Youth-led participatory action research. Handbook of methodological approaches to community-based research: Qualitative, quantitative, and mixed methods. 2016:263-272. 15.Cammarota J, Fine M. Revolutionizing education : youth participatory action research in motion. New York, NY: Routledge; 2008.
Cammarota J, Fine M. Revolutionizing education : youth participatory action research in motion. New York, NY: Routledge; 2008.
Halpern R. The means to grow up: Reinventing apprenticeship as a developmental support in adolescence. Routledge; 2013.

Layout table for additonal information
Responsible Party: Juliet Iwelunmor, PhD, Associate Professor in Global Health, Program Director, MPH Global Health Concentration, St. Louis University
ClinicalTrials.gov Identifier: NCT04070287     History of Changes
Other Study ID Numbers: 30347
1UG3HD096929-01 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2019    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Juliet Iwelunmor, PhD, St. Louis University:
HIV Prevention
HIV self-testing
young people
Nigeria
Additional relevant MeSH terms:
Layout table for MeSH terms
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs