HIV/AIDSNCT05213689
HIV Self-Testing and Comic Intervention With Refugee Adolescents and Youth
A study testing Educational comic book and HIV Self-testing in people with HIV/AIDS and HIV Infections, run by University of Toronto at 1 site in Canada.
Trial summary
HIV is the leading cause of death for adolescents and young people (AYP) in sub-SaharanAfrica (SSA). Uganda hosts 1.4 million refugees/displaced persons and the Bidi Bidi refugee camp in Northern Uganda is the second-largest refugee settlement in the world and the largest in Africa. Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, HIV Infections, Knowledge, Attitudes, Practice
- What is being tested?
- Educational comic book and HIV Self-testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2022to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- living in one of the selected villages in Zone 3 \& 4 Annex in the Bidi Bidi Refugee Settlement
- identify as a refugee/displaced person or have refugee parents
- aged 16-24 years
Who cannot join
- do not identify as a refugee or do not have refugee parents
- do not live in the selected villages in Zone 3 \& 4 Annex
Trial locations and contacts
1 site in 1 country.
Canada1 site
Factor-Inwentash Faculty of Social Work, University of Toronto
Toronto, Ontario, M5S1V4
About this study
Official title: Kuwawezesha Vijana (Empowering Youth): An HIV Self-Testing and Comic Intervention With Refugee Adolescents and Youth in a Refugee Settlement in Northern Uganda
HIV is the leading cause of death for adolescents and young people (AYP) in sub-SaharanAfrica (SSA). Uganda hosts 1.4 million refugees/displaced persons and the Bidi Bidi refugee camp in Northern Uganda is the second-largest refugee settlement in the world and the largest in Africa. There are reports of high sexual and gender-based violence (SGBV) among refugees during the journey from South Sudan to Uganda and in the refugee settlements, yet low rates of HIV testing and access to HIV prevention services, particularly tailored for gender, age, and the refugee settlement context. This study aims to develop, implement and evaluate an oral HIV-self testing (HIVST) intervention with displaced/refugee AYP aged16- 24 in Bidi Bidi. HIVST is acceptable and properly used with AYP in other SSA regions, yet there are knowledge gaps regarding the best way to link HIVST to HIV care. This study aims to explore how user-developed educational comic books can improve linkage to care with HIVST. This trial focuses on implementing a randomized trial with displaced/refugee AYP aged 16-24 living in Bidi Bidi (Arm1: HIVST; Arm 2: HIVST + comic book; Arm 3: comic book; Arm 4: standard of care). The study will assess changes in HIV testing practices, HIV status knowledge, and linkage to HIV prevention and care between the 4 arms.
Read the detailed description
The proposed study will take place in Bidi Bidi Refugee Settlement within Yumbe district in northwestern Uganda, hosting over 200,000 refugees.This research will be conducted in Zone 3 and 5 in Bidi Bidi. The proposed intervention involves a randomized controlled trial (RCT) to evaluate the effectiveness of HIVST delivery approaches on HIV testing uptake among refugee youth aged 16-24 in Bidi Bidi. Participants will be cluster-randomized in one of four study arms (Arm 1: HIVST; Arm 2: HIVST + comic book; Arm 3: comic book; Arm 4: standard of care). Participants from specific villages within two Bidi Bidi zones will be randomized to an arm together.
HIVST Interventions (Arm 1 and 2): At the first visit study participants are provided with a HIVST kit (Oraquick: approved and used in Uganda by the Ministry of Health) that is an oral swab test stick and tube solutions, and a written detailed step by step description of how to correctly use the HIVST kits, pictorial and written guide for HIVST kits, information on HIV and testing, referral cards with addresses and phone numbers to local clinics for confirmatory testing. The cards will also have a peer navigator (PN)'s phone numbers for participants to call or text message (SMS) if they need additional information on how to use the kits, or support to go to confirmatory tests at the clinics. Instructions for the kits are in English, Bari and Juba Arabic and reflect the context of the rural displaced adolescent and young people. The Research Coordinator and PN team will rotate being on-call to respond to any issues by text and will offer to phone or text support the participant and offer to make an appointment to see them and/or support them to attend a collaborating clinic for further support.
Educational comic book (Arm 2 and 3): Participants will receive an educational comic book focused on HIV testing information and decision making that was developed with qualitative data collected from an earlier study phase. PNs will meet with small groups of participants to read through and discuss the comic book together.
Standard of Care: PNs will provide information about HIV testing, care and support services at local clinics.
Participant retention: Community collaborators will facilitate recruitment and retention; PNs will use multiple study reminder strategies (e.g. social media, texts) to maintain engagement, and we will utilize existing outreach and services by Uganda Refugee and Disaster Management Council (URDMC).
Research Team Training: This research involves collaborations with local clinics and URDMC in Bidi Bidi. Clinic staff will provide technical assistance for HIVST and train PN and the research team in: a) using HIV rapid test kits (Alere Determine HIV-1/2); b) using OraQuick, a rapid oralHIVST used in Uganda; c) pre/post HIV test counselling; and d) linkages to confirmatory testing and HIV care.
Linkage to testing and care: Participants across all study arms will meet with PN at two timepoints (t0: baseline, t1: 3 months) to complete surveys. Each participant will have a study identification (ID) number printed on 'movie coupons'; they can bring these coupons to clinics for HIV testing, confirmatory testing, linkage to HIV care, sexual and reproductive health services.The survey ID will be linked to resources accessed. Persons who test positive will be linked with local support groups and services, which have been identified and will the linkage be facilitated by local collaborators URDMC.
- Conditions
- HIV/AIDS, HIV Infections, Knowledge, Attitudes, Practice
- Being tested
- Educational comic book, HIV Self-testing
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational comic bookBehavioural
An educational comic book was developed with qualitative data collected from an earlier study phase involving focus groups with youth from Bidi Bidi. The comic book is focused on HIV testing information and decision making as it follows the story of youth in Bidi Bidi who are seeking out HIV testing. Each youth in the appropriate arm with receive a copy of the comic book and together with 5-10 other youth will meet with a PN to read through and discuss the comic book. The comic will also include blank pages so that the youth can participate in the dialogue of the comic book. The comic will be available in English, Bari and Juba Arabic.
HIV Self-testingDiagnostic test
Participants will receive HIVST kits so that they can perform their HIV testing.
| Study group | Role | What they receive |
|---|---|---|
| HIV self-testing + educational comic book | Experimental | At the first visit participants will receive a HIVST kit and a detailed description of how to use the HIVST kits, pictorial and written guide for HIVST kits, in addition to contact information for confirmatory testing and linkage to care at local clinics. Participants will also receive an educational comic book focused on HIV testing information and decision making that was developed with qualitative data collected from an earlier study phase. PNs will meet with small groups of participants to read through and discuss the comic book together. Receives: Behavioral: Educational comic book; Diagnostic Test: HIV Self-testing |
| HIV self-testing | Active comparator | At the first visit participants will receive a HIVST kit and a detailed description of how to use the HIVST kits, pictorial and written guide for HIVST kits, in addition to contact information for confirmatory testing and linkage to care at local clinics. Receives: Diagnostic Test: HIV Self-testing |
| Educational comic book | Active comparator | Participants will receive an educational comic book focused on HIV testing information and decision making that was developed with qualitative data collected from an earlier study phase. PNs will meet with small groups of participants to read through and discuss the comic book together. Receives: Behavioral: Educational comic book |
| Standard of Care | No intervention | PNs will provide information about HIV testing, care and support services at local clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HIV testing frequency
To assess changes in past 3 month HIV testing frequencies, participants are asked to self-report when their last HIV test was and where their last HIV test was (if they used the HIVST, clinic, or point-of-care testing).
Measured: Time 1 (month 0), Time 2 (month 3)
HIV status knowledge
At the final 3-month visit, a clinician supported by trained peer navigators will offer all participants a completely voluntary rapid point-of-care HIV test (Alere Determine HIV-½) to measure HIV status knowledge. HIV status knowledge will be assessed as correct for participants that agree to take the rapid test and correctly report their HIV status before receiving the result.
Measured: Time 2 (month 3)
Secondary outcomes (10)
Linkage to confirmatory HIV testing
Interviewer will ask HIVST arms if they used their HIVST kit, for those who did, we will ask result. For those reporting a positive result we will ask if/where they received confirmatory testing. Participants can also submit coupons at collaborating health clinics with coupons with their study ID# for confirmatory tests that can be linked to study.
Measured: Time 2 (month 3)
Change in HIV-related stigma
Attitudes and beliefs towards HIV will be assessed using Steward et al., (2008) HIV-related stigma scale including vicarious and felt-normative HIV stigma dimensions.
Measured: Time 1 (month 0), Time 2 (month 3)
Change in HIV knowledge
HIV knowledge will be assessed using 18-item brief HIV knowledge questionnaire by Carey \& Schroder, 2002.
Measured: Time 1 (month 0), Time 2 (month 3)
Change in access to other sexual and reproductive health services
Interviewer will ask all participants to self-report their use of condoms (at time of last sex, % of times during sex in past 1 month), use of contraception [or partner's use for men] (current use [yes/no], type). Participants can also submit coupons at collaborating health clinics with coupons with their study ID# for SRH services that can be linked to study.
Measured: Time 1 (month 0), Time 2 (month 3)
Linkage to HIV care
Participants who seroconvert in the study will be asked if they received HIV care, including ART and counseling, since receiving an HIV-positive diagnosis.
Measured: Time 2 (month 3)
HIV self-test kit use
In order to understand the use of HIV self-test kits and to reduce social desirability bias, one month after Time 2 the participants in arm 1 and arm 2 will be asked if they have unused test kits. They will be informed this information is just to guide future trials.
Measured: One month after Time 2
Safer sex efficacy
Measured using the Condom Use Self-Efficacy Scale (Shaweno et al., \& Brafford et al.)
Measured: Time 1 (month 0), Time 2 (month 3)
Condom use
Measured using questions asking about condom use at last sex; condom use at sex every time in last 3 months [dichotomous: yes/no]
Measured: Time 1 (month 0), Time 2 (month 3)
Adolescent sexual and reproductive health stigma
Assessed with the Ugandan Adolescent Sexual and Reproductive Health (SRH) Stigma scale (Logie et al. 2019) adapted from Hall et al.'s Adolescent SRH Stigma scale
Measured: Time 1 (month 0), Time 2 (month 3)
Sexual relationship power
Measured using Relationship Control Sub-Scale from the Sexual \& Relationship Power Scale (Pulerwitz et al.)
Measured: Time 1 (month 0), Time 2 (month 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study startJun 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This cluster-randomized controlled trial (RCT) will evaluate the effectiveness of HIVST delivery approaches on HIV testing uptake among refugee youth in the Bidi Bidi Refugee Settlement. Participants from two villages within each of the two zones (i.e., four geographically different areas) will be randomized together to one of 4 study arms: Arm 1-HIVST, Arm 2- HIVST+ educational comic book, Arm 3-educational comic book, and Arm 4 - standard of care(control). Data collectors will administer tablet-based surveys (baseline and at 3 months).
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Principal investigator, Carmen Logie, MSW, PhD, University of Toronto
- Investigators
- Carmen Logie, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213689
- Sponsor's protocol ID
- bidibidi_viiv
- Status last verified
- May 2022
- First submitted
- 27 Jan 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Steward WT, Herek GM, Ramakrishna J, Bharat S, Chandy S, Wrubel J, Ekstrand ML. HIV-related stigma: adapting a theoretical framework for use in India. Soc Sci Med. 2008 Oct;67(8):1225-35. doi: 10.1016/j.socscimed.2008.05.032. Epub 2008 Jul 1.
PubMed 18599171Carey MP, Schroder KE. Development and psychometric evaluation of the brief HIV Knowledge Questionnaire. AIDS Educ Prev. 2002 Apr;14(2):172-82. doi: 10.1521/aeap.14.2.172.23902.
PubMed 12000234Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Shaweno D, Tekletsadik E. Validation of the condom use self-efficacy scale in Ethiopia. BMC Int Health Hum Rights. 2013 Apr 23;13:22. doi: 10.1186/1472-698X-13-22.
PubMed 23617404Brafford LJ, Beck KH. Development and validation of a condom self-efficacy scale for college students. J Am Coll Health. 1991 Mar;39(5):219-25. doi: 10.1080/07448481.1991.9936238.
PubMed 1783705Pulerwitz J, Gortmaker SL, Dejong W. Measuring Sexual Relationship Power in HIV/STD Research. Sex Roles. 2000;42:637-60.
Hall KS, Manu A, Morhe E, Harris LH, Loll D, Ela E, Kolenic G, Dozier JL, Challa S, Zochowski MK, Boakye A, Adanu R, Dalton VK. Development and Validation of a Scale to Measure Adolescent Sexual and Reproductive Health Stigma: Results From Young Women in Ghana. J Sex Res. 2018 Jan;55(1):60-72. doi: 10.1080/00224499.2017.1292493. Epub 2017 Mar 7.
PubMed 28266874Logie CH, Okumu M, Mwima SP, Kyambadde P, Hakiza R, Kibathi IP, Kironde E, Musinguzi J, Kipenda CU. Exploring associations between adolescent sexual and reproductive health stigma and HIV testing awareness and uptake among urban refugee and displaced youth in Kampala, Uganda. Sex Reprod Health Matters. 2019 Dec;27(3):86-106. doi: 10.1080/26410397.2019.1695380.
PubMed 31880507Logie CH, Okumu M, Loutet MG, Coelho M, Berry I, Gittings L, Odong Lukone S, Kisubi N, Atama M, Kyambadde P. Todurujo na Kadurok (empowering youth): study protocol of an HIV self-testing and edutainment comic cluster randomised trial among refugee youth in a humanitarian setting in Uganda. BMJ Open. 2022 Nov 23;12(11):e065452. doi: 10.1136/bmjopen-2022-065452.
PubMed 36418143
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kuwawezesha Vijana (Empowering Youth): An HIV Self-Testing and Comic Intervention With Refugee Adolescents and Youth in a Refugee Settlement in Northern Uganda
- ClinicalTrials.gov ID
- NCT05213689
- Acronym / sponsor ID
- bidibidi_viiv
- Conditions
- HIV/AIDS, HIV Infections, Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- Jun 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HIV is the leading cause of death for adolescents and young people (AYP) in sub-SaharanAfrica (SSA). Uganda hosts 1.4 million refugees/displaced persons and the Bidi Bidi refugee camp in Northern Uganda is the second-largest refugee settlement in the world and the largest in Africa. There are reports of high sexual and gender-based violence (SGBV) among refugees during the journey from South Sudan to Uganda and in the refugee settlements, yet low rates of HIV testing and access to HIV prevention services, particularly tailored for gender, age, and the refugee settlement context. This study aims to develop, implement and evaluate an oral HIV-self testing (HIVST) intervention with displaced/refugee AYP aged16- 24 in Bidi Bidi. HIVST is acceptable and properly used with AYP in other SSA regions, yet there are knowledge gaps regarding the best way to link HIVST to HIV care. This study aims to explore how user-developed educational comic books can improve linkage to care with HIVST. This trial focuses on implementing a randomized trial with displaced/refugee AYP aged 16-24 living in Bidi Bidi (Arm1: HIVST; Arm 2: HIVST + comic book; Arm 3: comic book; Arm 4: standard of care). The study will assess changes in HIV testing practices, HIV status knowledge, and linkage to HIV prevention and care between the 4 arms.
Detailed description
The proposed study will take place in Bidi Bidi Refugee Settlement within Yumbe district in northwestern Uganda, hosting over 200,000 refugees.This research will be conducted in Zone 3 and 5 in Bidi Bidi. The proposed intervention involves a randomized controlled trial (RCT) to evaluate the effectiveness of HIVST delivery approaches on HIV testing uptake among refugee youth aged 16-24 in Bidi Bidi. Participants will be cluster-randomized in one of four study arms (Arm 1: HIVST; Arm 2: HIVST + comic book; Arm 3: comic book; Arm 4: standard of care). Participants from specific villages within two Bidi Bidi zones will be randomized to an arm together.
HIVST Interventions (Arm 1 and 2): At the first visit study participants are provided with a HIVST kit (Oraquick: approved and used in Uganda by the Ministry of Health) that is an oral swab test stick and tube solutions, and a written detailed step by step description of how to correctly use the HIVST kits, pictorial and written guide for HIVST kits, information on HIV and testing, referral cards with addresses and phone numbers to local clinics for confirmatory testing. The cards will also have a peer navigator (PN)'s phone numbers for participants to call or text message (SMS) if they need additional information on how to use the kits, or support to go to confirmatory tests at the clinics. Instructions for the kits are in English, Bari and Juba Arabic and reflect the context of the rural displaced adolescent and young people. The Research Coordinator and PN team will rotate being on-call to respond to any issues by text and will offer to phone or text support the participant and offer to make an appointment to see them and/or support them to attend a collaborating clinic for further support.
Educational comic book (Arm 2 and 3): Participants will receive an educational comic book focused on HIV testing information and decision making that was developed with qualitative data collected from an earlier study phase. PNs will meet with small groups of participants to read through and discuss the comic book together.
Standard of Care: PNs will provide information about HIV testing, care and support services at local clinics.
Participant retention: Community collaborators will facilitate recruitment and retention; PNs will use multiple study reminder strategies (e.g. social media, texts) to maintain engagement, and we will utilize existing outreach and services by Uganda Refugee and Disaster Management Council (URDMC).
Research Team Training: This research involves collaborations with local clinics and URDMC in Bidi Bidi. Clinic staff will provide technical assistance for HIVST and train PN and the research team in: a) using HIV rapid test kits (Alere Determine HIV-1/2); b) using OraQuick, a rapid oralHIVST used in Uganda; c) pre/post HIV test counselling; and d) linkages to confirmatory testing and HIV care.
Linkage to testing and care: Participants across all study arms will meet with PN at two timepoints (t0: baseline, t1: 3 months) to complete surveys. Each participant will have a study identification (ID) number printed on 'movie coupons'; they can bring these coupons to clinics for HIV testing, confirmatory testing, linkage to HIV care, sexual and reproductive health services.The survey ID will be linked to resources accessed. Persons who test positive will be linked with local support groups and services, which have been identified and will the linkage be facilitated by local collaborators URDMC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This cluster-randomized controlled trial (RCT) will evaluate the effectiveness of HIVST delivery approaches on HIV testing uptake among refugee youth in the Bidi Bidi Refugee Settlement. Participants from two villages within each of the two zones (i.e., four geographically different areas) will be randomized together to one of 4 study arms: Arm 1-HIVST, Arm 2- HIVST+ educational comic book, Arm 3-educational comic book, and Arm 4 - standard of care(control). Data collectors will administer tablet-based surveys (baseline and at 3 months).
| Arm | Type | Receives |
|---|---|---|
| HIV self-testing + educational comic book | Experimental | Behavioral: Educational comic book, Diagnostic Test: HIV Self-testingAt the first visit participants will receive a HIVST kit and a detailed description of how to use the HIVST kits, pictorial and written guide for HIVST kits, in addition to contact information for confirmatory testing and linkage to care at local clinics. Participants will also receive an educational comic book focused on HIV testing information and decision making that was developed with qualitative data collected from an earlier study phase. PNs will meet with small groups of participants to read through and discuss the comic book together. |
| HIV self-testing | Active comparator | Diagnostic Test: HIV Self-testingAt the first visit participants will receive a HIVST kit and a detailed description of how to use the HIVST kits, pictorial and written guide for HIVST kits, in addition to contact information for confirmatory testing and linkage to care at local clinics. |
| Educational comic book | Active comparator | Behavioral: Educational comic bookParticipants will receive an educational comic book focused on HIV testing information and decision making that was developed with qualitative data collected from an earlier study phase. PNs will meet with small groups of participants to read through and discuss the comic book together. |
| Standard of Care | No intervention | –PNs will provide information about HIV testing, care and support services at local clinics. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- living in one of the selected villages in Zone 3 \& 4 Annex in the Bidi Bidi Refugee Settlement
- identify as a refugee/displaced person or have refugee parents
- aged 16-24 years
Key exclusion criteria (2 listed)
- do not identify as a refugee or do not have refugee parents
- do not live in the selected villages in Zone 3 \& 4 Annex
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational comic bookAn educational comic book was developed with qualitative data collected from an earlier study phase involving focus groups with youth from Bidi Bidi. The comic book is focused on HIV testing information and decision making as it follows the story of youth in Bidi Bidi who are seeking out HIV testing. Each youth in the appropriate arm with receive a copy of the comic book and together with 5-10 other youth will meet with a PN to read through and discuss the comic book. The comic will also include blank pages so that the youth can participate in the dialogue of the comic book. The comic will be available in English, Bari and Juba Arabic. | Behavioural | Educational comic book, HIV self-testing + educational comic book |
| HIV Self-testingParticipants will receive HIVST kits so that they can perform their HIV testing. | Diagnostic test | HIV self-testing, HIV self-testing + educational comic book |
Primary outcome
Changes in HIV testing frequency
Time frame: Time 1 (month 0), Time 2 (month 3)
To assess changes in past 3 month HIV testing frequencies, participants are asked to self-report when their last HIV test was and where their last HIV test was (if they used the HIVST, clinic, or point-of-care testing).
HIV status knowledge
Time frame: Time 2 (month 3)
At the final 3-month visit, a clinician supported by trained peer navigators will offer all participants a completely voluntary rapid point-of-care HIV test (Alere Determine HIV-½) to measure HIV status knowledge. HIV status knowledge will be assessed as correct for participants that agree to take the rapid test and correctly report their HIV status before receiving the result.
10 secondary outcomes
Linkage to confirmatory HIV testing
Time frame: Time 2 (month 3)
Change in HIV-related stigma
Time frame: Time 1 (month 0), Time 2 (month 3)
Change in HIV knowledge
Time frame: Time 1 (month 0), Time 2 (month 3)
Change in access to other sexual and reproductive health services
Time frame: Time 1 (month 0), Time 2 (month 3)
Linkage to HIV care
Time frame: Time 2 (month 3)
HIV self-test kit use
Time frame: One month after Time 2
Safer sex efficacy
Time frame: Time 1 (month 0), Time 2 (month 3)
Condom use
Time frame: Time 1 (month 0), Time 2 (month 3)
Adolescent sexual and reproductive health stigma
Time frame: Time 1 (month 0), Time 2 (month 3)
Sexual relationship power
Time frame: Time 1 (month 0), Time 2 (month 3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Background: PubMed 18599171Steward WT, Herek GM, Ramakrishna J, Bharat S, Chandy S, Wrubel J, Ekstrand ML. HIV-related stigma: adapting a theoretical framework for use in India. Soc Sci Med. 2008 Oct;67(8):1225-35. doi: 10.1016/j.socscimed.2008.05.032. Epub 2008 Jul 1.
- Background: PubMed 12000234Carey MP, Schroder KE. Development and psychometric evaluation of the brief HIV Knowledge Questionnaire. AIDS Educ Prev. 2002 Apr;14(2):172-82. doi: 10.1521/aeap.14.2.172.23902.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Background: PubMed 23617404Shaweno D, Tekletsadik E. Validation of the condom use self-efficacy scale in Ethiopia. BMC Int Health Hum Rights. 2013 Apr 23;13:22. doi: 10.1186/1472-698X-13-22.
- Background: PubMed 1783705Brafford LJ, Beck KH. Development and validation of a condom self-efficacy scale for college students. J Am Coll Health. 1991 Mar;39(5):219-25. doi: 10.1080/07448481.1991.9936238.
- BackgroundPulerwitz J, Gortmaker SL, Dejong W. Measuring Sexual Relationship Power in HIV/STD Research. Sex Roles. 2000;42:637-60.
- Background: PubMed 28266874Hall KS, Manu A, Morhe E, Harris LH, Loll D, Ela E, Kolenic G, Dozier JL, Challa S, Zochowski MK, Boakye A, Adanu R, Dalton VK. Development and Validation of a Scale to Measure Adolescent Sexual and Reproductive Health Stigma: Results From Young Women in Ghana. J Sex Res. 2018 Jan;55(1):60-72. doi: 10.1080/00224499.2017.1292493. Epub 2017 Mar 7.
- Background: PubMed 31880507Logie CH, Okumu M, Mwima SP, Kyambadde P, Hakiza R, Kibathi IP, Kironde E, Musinguzi J, Kipenda CU. Exploring associations between adolescent sexual and reproductive health stigma and HIV testing awareness and uptake among urban refugee and displaced youth in Kampala, Uganda. Sex Reprod Health Matters. 2019 Dec;27(3):86-106. doi: 10.1080/26410397.2019.1695380.
- Derived from this study: PubMed 36418143Logie CH, Okumu M, Loutet MG, Coelho M, Berry I, Gittings L, Odong Lukone S, Kisubi N, Atama M, Kyambadde P. Todurujo na Kadurok (empowering youth): study protocol of an HIV self-testing and edutainment comic cluster randomised trial among refugee youth in a humanitarian setting in Uganda. BMJ Open. 2022 Nov 23;12(11):e065452. doi: 10.1136/bmjopen-2022-065452.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Logie, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational comic book and HIV Self-testing in people with HIV/AIDS and HIV Infections, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmen Logie, PhD (6474544203, carmen.logie@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HIV testing frequency (time frame: Time 1 (month 0), Time 2 (month 3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05213689, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.