Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06270160
Other study ID # KampalaLivelihoodsStudy
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date December 31, 2024

Study information

Verified date February 2024
Source University of Toronto
Contact Carmen Logie, PhD
Phone 6474544203
Email carmen.logie@utoronto.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Displaced and refugee youth in Uganda are more vulnerable to health risks due to financial insecurity. As such, the investigators aim to explore the utility of an intervention aimed at improving livelihoods, called Creating Futures. Creating Futures is a group intervention that aims to help young people build their livelihoods, and was designed for use with youth (18-24) in urban informal settlements in South Africa. Since there is a dearth of knowledge regarding efficacious interventions in refugee camps/settlements to engage young people in HIV testing and linkage to care, the investigators will harness various health promotion techniques including mHealth, comics, and the Creating Futures livelihoods intervention to address the urgent needs for: 1) HIV testing interventions with refugee/displaced adolescent and young people in Kampala, and 2) innovative HIV self test (HIVST) delivery strategies to increase linkage to confirmatory testing and HIV care. The investigators will conduct a three-arm cluster randomized controlled trial (cRCT) to evaluate the effectiveness of HIVST delivery methods among AYP living in Kampala. The specific objectives are to: Evaluate the feasibility and effectiveness of: 1) HIVST alone; 2) HIVST in combination with mHealth; and 3) HIVST, mHealth and Creating Futures in combination in increasing routine HIV testing, HIV status knowledge, and linkage to confirmatory testing and HIV care. The investigators aim to examine if adding a livelihoods program to HIV self-testing improves HIV prevention outcomes and other facets of well-being among urban refugee youth in Kampala.


Description:

As of March 2021, the prevalence of HIV among Ugandan youth aged 15-24 years was estimated at almost 2%, with young women and adolescent girls having an HIV prevalence over three times that of young men and adolescent boys (2.9% vs. 0.8%). The prevalence of HIV among youth living in Kampala's slums is even higher, at an estimated 13.9-37.2%. This high prevalence may be driven by factors such as food scarcity, limited infrastructure, lack of social support, stigma, and gender norms, which may limit the condom negation and use of HIV testing services among youth. Uganda hosts over 1.5 million refugees, 8% of which reside in Kampala, and many living within slums or informal settlements. While the UNAIDS Gap report identified displaced persons and adolescent girls and young women as populations at high-risk for HIV infection, the HIV prevalence among Uganda's refugees is largely unknown due to the lack of standardized surveillance of refugees. One approach to improve HIV testing among displaced persons in Uganda is through HIV self-testing (HIVST). HIVST involves a person collecting their own specimen (blood or saliva), conducting the test, and interpreting the results. HIVST has the potential to reduce testing barriers such as stigma and privacy, while enhancing confidentiality and convenience, which are important considerations for adolescents and young people. Innovative HIVST delivery strategies are urgently needed to link persons with positive HIVST results to confirmatory testing and HIV care. As such, identifying strategies to promote linkage to HIV care is essential to realize the public health impact of HIVST. Since there is a dearth of knowledge regarding efficacious interventions in refugee camps/settlements to engage young people in HIV testing and linkage to care, the investigators will harness various health promotion techniques including mHealth, comics, and the Creating Futures livelihoods intervention to address the urgent needs for: 1) HIV testing interventions with refugee/displaced adolescent and young people in Kampala, and 2) innovative HIVST delivery strategies to increase linkage to confirmatory testing and HIV care. The investigators will evaluate the feasibility and effectiveness of: 1) HIVST alone; 2) HIVST in combination with mHealth; and 3) HIVST, mHealth and Creating Futures in combination in increasing routine HIV testing, HIV status knowledge, and linkage to confirmatory testing and HIV care. The investigators aim to examine if adding a livelihoods program to HIV self-testing improves HIV prevention outcomes and other facets of well-being among urban refugee youth in Kampala. Mobile health (mHealth) can be used to facilitate HIVST adherence among displaced youth through mobile phone (mHealth) reminders. mHealth approaches are germane to low and middle-income countries (LMIC), where cell phone ownership is rising rapidly, but access to health care is often limited. In Uganda, over 13 million persons have access to mobile phones, and data suggest that HIV prevention messages through mobile phones are beneficial to supplement traditional modalities such as schools for adolescents. Educational comics offer a youth-friendly, low-cost, scalable approach for providing education and health promotion on health topics such as HIV, sexually transmitted infections, vaccines, and dementia. Comics have been used to educate both the general population and healthcare providers to improve care and patient experiences, as they are accessible, do not require high levels of literacy, and can encourage participants to envision and share solutions to sexual violence through facilitating dialogue around emotionally difficult and often stigmatized issues. Creating Futures is a group intervention that aims to help young people build their livelihoods and was designed for use with youth in urban informal settlements in South Africa. Previous researchers have implemented the Creating Futures intervention in South Africa and found that after the intervention, men's earnings increased, women's experiences of intimate partner violence decreased, men and women scored better on gender attitudes, and depression and suicidal thoughts decreased amongst men. The investigators will conduct a three-arm cluster randomized controlled trial (cRCT) to evaluate the effectiveness of HIVST delivery methods among youth living in Kampala. The five informal settlements in Kampala will be randomized in a 1:1:1 approach to one of the three study arms. The five informal settlements will be grouped into three sites based on close geographic proximity (1: Kabalagala and Kansanga, 2: Katwe and Nsambya, and 3: Rubaga). The investigators used the following criteria to select informal settlements: 1) settlements that host a large number of refugees or displaced persons; 2) communities with similar measures of socioeconomic status, healthcare access, languages, and living conditions; and 3) evidence of a high prevalence of depressive symptoms among urban refugee youth. Participants will be allocated to a study arm based on their informal settlement of residence. Youth living in slums and informal settlements have shared socio-physical environments. As such, except for individual-level outcome data, the investigators will use a cluster-randomized approach to limit challenges posed by experimental contamination and threats to internal validity. Data collection will be performed at baseline, and 3- and 6-months post-intervention implementation. The investigators are working with study collaborators from Young African Refugees for Integral Development (YARID), a nongovernmental youth refugee organization in Kampala, who have been involved since the initial research question and focus development stage. The study protocol was developed after a formative qualitative research phase (Phase 1), which included semi-structured interviews with peer navigators and other key informants (e.g., refugee health professionals, migrant workers, teen mothers). Refugee youth aged 18-24 years (12: 6 men, 6 women), living in the same informal settlements who are trained in research methods and ethics will act as peer navigators and enroll other youth in the study after obtaining written informed consent. The investigators employed purposive methods to recruit participants, such as word-of-mouth and venue-based sampling at community events and refugee agencies, beginning with participants who belonged to the Tushirkiane cohort and participated in previous trials on HIVST, COVID-19 prevention, and mental health interventions. The investigators will refresh the cohort with additional purposive recruitment of 16- and 17-year-old participants. The use of SMS and WhatsApp reminders from peer navigators and outreach events allows for the continued engagement and retention of study participants. Data collection will be conducted by research assistants trained by the Ministry of Health in pre- and post-test counselling. Data will be collected using a structured survey accessed via mobile phones or tablets in all study languages via the SurveyCTO app (Dobility). This app houses a secure platform and automatically encrypts data, which are then uploaded with a Secure Sockets Layer (SSL) certificate to a password-protected server. The use of SurveyCTO allows for multilingual and offline data collection with branching logic and consistency checks. All participants are assigned a unique ID number without any personal identifying information to enhance confidentiality. The analysis and reporting of this study will be conducted following the CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study analyst will be blinded to group allocation. Participant flow (screening, randomization, allocation, follow-up) will be illustrated using a flow diagram. The investigators will report baseline data for all groups summarized using mean (standard deviation) or median (first and third quartiles) for continuous variables and counts and frequencies (percent) for categorical variables. The investigators will use an intention-to-treat approach with a complete data set whereby participants will be analyzed according to their initial group allocation irrespective of whether they received said intervention.


Recruitment information / eligibility

Status Recruiting
Enrollment 432
Est. completion date December 31, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 25 Years
Eligibility Inclusion Criteria: - Living in one of the five selected Kampala informal settlements (Kabalagala, Kansanga, Katwe, Nsambya, or Rubaga) - Identify as a displaced person, refugee, or as having a refugee or displaced parent(s) - Aged 16-25 years - Own or have daily access to a mobile phone - Speak French, English, Kirundi, Kinyarwanda, or Swahili Exclusion Criteria: - Not living in one of the five selected informal settlements - Does not identify as a displaced person, refugee, or as having a refugee or displaced parent(s) - Aged 15 and under or 26 and older - Does not have access to a mobile phone or shares a phone - Does not speak one of French, English, Kirundi, Kinyarwanda, or Swahili

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
HIVST
Peer navigators will demonstrate how to use an HIVST kit, including how to 1) open the kit, 2) collect the oral fluid samples, and 3) read the results. In addition to HIVST education, participants will be offered optional pre-test counselling and SMS contact information to connect with their peer navigator. If participants do not want post-test counselling, the PN will follow up within two weeks. If the participants report testing positive, then they will be immediately scheduled for confirmatory testing and enrolled in the support programs at MARPI for young people living with HIV.
Device:
mHealth
The investigators are collaborating with the WelTel non-profit agency for a supportive SMS intervention. The WelTel system will manage the SMS intervention on their structured mobile phone platform (all SMS interactions are logged). Weekly 2-way supportive messages will automatically be sent on the same weekday with WelTel software to Arm 2+3 participants. The peer navigator will ask Arm 2+3 participants to respond to the SMS within 48 hours to confirm their wellbeing and will follow-up with non-responders. The Arm 2+3 peer navigators and Research Coordinator will access the server every 24-48 hours to triage and respond to participants who express a problem or need.
Behavioral:
Creating Futures Livelihoods program
Creating Futures is a group intervention that aims to help young people build their livelihoods, and was designed for use with youth (18-24) in urban informal settlements in South Africa.

Locations

Country Name City State
Uganda Young African Refugees for Integral Development Kampala

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Country where clinical trial is conducted

Uganda, 

References & Publications (50)

Baral S, Logie CH, Grosso A, Wirtz AL, Beyrer C. Modified social ecological model: a tool to guide the assessment of the risks and risk contexts of HIV epidemics. BMC Public Health. 2013 May 17;13:482. doi: 10.1186/1471-2458-13-482. — View Citation

Bland JM, Altman DG. Multiple significance tests: the Bonferroni method. BMJ. 1995 Jan 21;310(6973):170. doi: 10.1136/bmj.310.6973.170. No abstract available. — View Citation

Bogart LM, Kgotlaetsile K, Phaladze N, Mosepele M. HIV self-testing may overcome stigma and other barriers to HIV testing among higher-socioeconomic status men in Botswana: A qualitative study. Afr J AIDS Res. 2021 Dec;20(4):297-306. doi: 10.2989/16085906.2021.2000450. — View Citation

Brown W 3rd, Carballo-Dieguez A, John RM, Schnall R. Information, Motivation, and Behavioral Skills of High-Risk Young Adults to Use the HIV Self-Test. AIDS Behav. 2016 Sep;20(9):2000-9. doi: 10.1007/s10461-016-1309-x. — View Citation

Cambiano V, Mavedzenge SN, Phillips A. Modelling the potential population impact and cost-effectiveness of self-testing for HIV: evaluation of data requirements. AIDS Behav. 2014 Jul;18 Suppl 4(Suppl 4):S450-8. doi: 10.1007/s10461-014-0824-x. — View Citation

Carey 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. — View Citation

Catania JA, Dolcini MM, Harper GW, Dowhower DP, Dolcini-Catania LG, Towner SL, Timmons A, Motley DN, Tyler DH. Bridging barriers to clinic-based HIV testing with new technology: translating self-implemented testing for African American youth. Transl Behav Med. 2015 Dec;5(4):372-83. doi: 10.1007/s13142-015-0331-2. Epub 2015 Jun 9. — View Citation

Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583. — View Citation

Choko AT, MacPherson P, Webb EL, Willey BA, Feasy H, Sambakunsi R, Mdolo A, Makombe SD, Desmond N, Hayes R, Maheswaran H, Corbett EL. Uptake, Accuracy, Safety, and Linkage into Care over Two Years of Promoting Annual Self-Testing for HIV in Blantyre, Malawi: A Community-Based Prospective Study. PLoS Med. 2015 Sep 8;12(9):e1001873. doi: 10.1371/journal.pmed.1001873. eCollection 2015 Sep. — View Citation

Culbreth R, Swahn MH, Salazar LF, Ametewee LA, Kasirye R. Risk Factors Associated with HIV, Sexually Transmitted Infections (STI), and HIV/STI Co-infection Among Youth Living in the Slums of Kampala, Uganda. AIDS Behav. 2020 Apr;24(4):1023-1031. doi: 10.1007/s10461-019-02444-5. — View Citation

Embleton L, Di Ruggiero E, Logie CH, Ayuku D, Braitstein P. Improving livelihoods and gender equitable attitudes of street-connected young people in Eldoret, Kenya: Results from a pilot evidence-based intervention. Health Soc Care Community. 2021 Jan;29(1):227-240. doi: 10.1111/hsc.13086. Epub 2020 Jul 7. — View Citation

Embleton L, Di Ruggiero E, Odep Okal E, Chan AK, Logie CH, Ayuku D, Braitstein P. Adapting an evidence-based gender, livelihoods, and HIV prevention intervention with street-connected young people in Eldoret, Kenya. Glob Public Health. 2019 Dec;14(12):1703-1717. doi: 10.1080/17441692.2019.1625940. Epub 2019 Jun 4. — View Citation

Gallagher-Thompson D, Tzuang M, Hinton L, Alvarez P, Rengifo J, Valverde I, Chen N, Emrani T, Thompson LW. Effectiveness of a fotonovela for reducing depression and stress in Latino dementia family caregivers. Alzheimer Dis Assoc Disord. 2015 Apr-Jun;29(2):146-53. doi: 10.1097/WAD.0000000000000077. — View Citation

Govindasamy D, Meghij J, Kebede Negussi E, Clare Baggaley R, Ford N, Kranzer K. Interventions to improve or facilitate linkage to or retention in pre-ART (HIV) care and initiation of ART in low- and middle-income settings--a systematic review. J Int AIDS Soc. 2014 Aug 1;17(1):19032. doi: 10.7448/IAS.17.1.19032. eCollection 2014. — View Citation

Hawk ME, Chung A, Creasy SL, Egan JE. A Scoping Review of Patient Preferences for HIV Self-Testing Services in the United States: Implications for Harm Reduction. Patient Prefer Adherence. 2020 Dec 2;14:2365-2375. doi: 10.2147/PPA.S251677. eCollection 2020. — View Citation

Jewkes R, Gibbs A, Jama-Shai N, Willan S, Misselhorn A, Mushinga M, Washington L, Mbatha N, Skiweyiya Y. Stepping Stones and Creating Futures intervention: shortened interrupted time series evaluation of a behavioural and structural health promotion and violence prevention intervention for young people in informal settlements in Durban, South Africa. BMC Public Health. 2014 Dec 29;14:1325. doi: 10.1186/1471-2458-14-1325. — View Citation

Jewkes R. Comprehensive response to rape needed in conflict settings. Lancet. 2007 Jun 30;369(9580):2140-2141. doi: 10.1016/S0140-6736(07)60991-X. No abstract available. — View Citation

Johnson C, Baggaley R, Forsythe S, van Rooyen H, Ford N, Napierala Mavedzenge S, Corbett E, Natarajan P, Taegtmeyer M. Realizing the potential for HIV self-testing. AIDS Behav. 2014 Jul;18 Suppl 4:S391-5. doi: 10.1007/s10461-014-0832-x. — View Citation

Johnson CC, Kennedy C, Fonner V, Siegfried N, Figueroa C, Dalal S, Sands A, Baggaley R. Examining the effects of HIV self-testing compared to standard HIV testing services: a systematic review and meta-analysis. J Int AIDS Soc. 2017 May 15;20(1):21594. doi: 10.7448/IAS.20.1.21594. — View Citation

Krasnoryadtseva A, Dalbeth N, Petrie KJ. The effect of different styles of medical illustration on information comprehension, the perception of educational material and illness beliefs. Patient Educ Couns. 2020 Mar;103(3):556-562. doi: 10.1016/j.pec.2019.09.026. Epub 2019 Sep 27. — View Citation

Logie C, Okumu M, Hakiza R, Kibuuka Musoke D, Berry I, Mwima S, Kyambadde P, Kiera UM, Loutet M, Neema S, Newby K, McNamee C, Baral SD, Lester R, Musinguzi J, Mbuagbaw L. Mobile Health-Supported HIV Self-Testing Strategy Among Urban Refugee and Displaced Youth in Kampala, Uganda: Protocol for a Cluster Randomized Trial (Tushirikiane, Supporting Each Other). JMIR Res Protoc. 2021 Feb 2;10(2):e26192. doi: 10.2196/26192. — View Citation

Logie CH, Berry I, Okumu M, Loutet M, McNamee C, Hakiza R, Musoke DK, Mwima S, Kyambadde P, Mbuagbaw L. The prevalence and correlates of depression before and after the COVID-19 pandemic declaration among urban refugee adolescents and youth in informal settlements in Kampala, Uganda: A longitudinal cohort study. Ann Epidemiol. 2022 Feb;66:37-43. doi: 10.1016/j.annepidem.2021.11.005. Epub 2021 Nov 14. — View Citation

Logie CH, Okumu M, Berry I, Hakiza R, Baral SD, Musoke DK, Nakitende A, Mwima S, Kyambadde P, Loutet M, Batte S, Lester R, Neema S, Newby K, Mbuagbaw L. Findings from the Tushirikiane mobile health (mHealth) HIV self-testing pragmatic trial with refugee adolescents and youth living in informal settlements in Kampala, Uganda. J Int AIDS Soc. 2023 Oct;26(10):e26185. doi: 10.1002/jia2.26185. — View Citation

Logie CH, Okumu M, Berry I, Hakiza R, Kibuuka Musoke D, Kyambadde P, Mwima S, Lester RT, Perez-Brumer AG, Baral S, Mbuagbaw L. Kukaa Salama (Staying Safe): study protocol for a pre/post-trial of an interactive mHealth intervention for increasing COVID-19 prevention practices with urban refugee youth in Kampala, Uganda. BMJ Open. 2021 Nov 22;11(11):e055530. doi: 10.1136/bmjopen-2021-055530. — View Citation

Logie CH, Okumu M, Kortenaar JL, Gittings L, Khan N, Hakiza R, Kibuuka Musoke D, Nakitende A, Katisi B, Kyambadde P, Khan T, Lester R, Mbuagbaw L. Mobile Health-Supported Virtual Reality and Group Problem Management Plus: Protocol for a Cluster Randomized Trial Among Urban Refugee and Displaced Youth in Kampala, Uganda (Tushirikiane4MH, Supporting Each Other for Mental Health). JMIR Res Protoc. 2022 Dec 8;11(12):e42342. doi: 10.2196/42342. — View Citation

Logie CH, Okumu M, Mwima S, Hakiza R, Chemutai D, Kyambadde P. Contextual factors associated with depression among urban refugee and displaced youth in Kampala, Uganda: findings from a cross-sectional study. Confl Health. 2020 Jul 10;14:45. doi: 10.1186/s13031-020-00289-7. eCollection 2020. — View Citation

Logie CH, Okumu M, Mwima S, Hakiza R, Irungi KP, Kyambadde P, Kironde E, Narasimhan M. Social ecological factors associated with experiencing violence among urban refugee and displaced adolescent girls and young women in informal settlements in Kampala, Uganda: a cross-sectional study. Confl Health. 2019 Dec 17;13:60. doi: 10.1186/s13031-019-0242-9. eCollection 2019. — View Citation

Lyytinen E. Informal places of protection: Congolese refugees' 'communities of trust' in Kampala, Uganda. Journal of Ethnic and Migration Studies. 2017 Apr 26;43(6):991-1008.

Misselhorn A, Mushinga M, Jama-Shai N, Washington L, Mbatha M. Creating Futures: Supporting Young People in Building their Livelihoods. Health Economics and HIV and AIDS Research Division (HEARD), University of KwaZulu-Natal. 2013.

Mitchell KJ, Bull S, Kiwanuka J, Ybarra ML. Cell phone usage among adolescents in Uganda: acceptability for relaying health information. Health Educ Res. 2011 Oct;26(5):770-81. doi: 10.1093/her/cyr022. Epub 2011 May 2. — View Citation

Muzumdar JM, Pantaleo NL. Comics as a Medium for Providing Information on Adult Immunizations. J Health Commun. 2017 Oct;22(10):783-791. doi: 10.1080/10810730.2017.1355418. Epub 2017 Sep 13. — View Citation

Noble E, Ward L, French S, Falb K. State of the Evidence: A Systematic Review of Approaches to Reduce Gender-Based Violence and Support the Empowerment of Adolescent Girls in Humanitarian Settings. Trauma Violence Abuse. 2019 Jul;20(3):428-434. doi: 10.1177/1524838017699601. Epub 2017 Mar 21. — View Citation

O'Laughlin KN, Kasozi J, Rabideau DJ, Parker RA, Mulogo E, Faustin ZM, Greenwald KE, Doraiswamy S, Walensky RP, Bassett IV. The cascade of HIV care among refugees and nationals in Nakivale Refugee Settlement in Uganda. HIV Med. 2017 Aug;18(7):513-518. doi: 10.1111/hiv.12476. Epub 2017 Jan 10. — View Citation

O'Laughlin KN, Rabideau DJ, Kasozi J, Parker RA, Bustamante ND, Faustin ZM, Greenwald KE, Walensky RP, Bassett IV. Predictors of HIV infection: a prospective HIV screening study in a Ugandan refugee settlement. BMC Infect Dis. 2016 Nov 23;16(1):695. doi: 10.1186/s12879-016-2021-1. — View Citation

Pai NP, Thomas R. Time for HIV self-testing in Canada: a vision and an action plan. CMAJ. 2020 Nov 2;192(44):E1367-E1368. doi: 10.1503/cmaj.201160. No abstract available. — View Citation

Rubenstein BL, Stark L. The impact of humanitarian emergencies on the prevalence of violence against children: an evidence-based ecological framework. Psychol Health Med. 2017 Mar;22(sup1):58-66. doi: 10.1080/13548506.2016.1271949. Epub 2017 Jan 9. — View Citation

Sawadogo PM, Sia D, Onadja Y, Beogo I, Sangli G, Sawadogo N, Gnambani A, Bassinga G, Robins S, Tchouaket Nguemeleu E. Barriers and facilitators of access to sexual and reproductive health services among migrant, internally displaced, asylum seeking and refugee women: A scoping review. PLoS One. 2023 Sep 14;18(9):e0291486. doi: 10.1371/journal.pone.0291486. eCollection 2023. — View Citation

Schober P, Vetter TR. Adjustments for Multiple Testing in Medical Research. Anesth Analg. 2020 Jan;130(1):99. doi: 10.1213/ANE.0000000000004545. No abstract available. — View Citation

Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010 Jun 1;152(11):726-32. doi: 10.7326/0003-4819-152-11-201006010-00232. Epub 2010 Mar 24. — View Citation

Shin MB, Ko LK, Ibrahim A, Mohamed FB, Lin J, Celentano I, Shankar M, Amsalu F, Ali AA, Richardson BA, Taylor VM, Winer RL. The Impact of a Comic Book Intervention on East African-American Adolescents' HPV Vaccine-Related Knowledge, Beliefs and Intentions. J Immigr Minor Health. 2022 Dec;24(6):1489-1500. doi: 10.1007/s10903-022-01359-z. Epub 2022 Mar 31. — View Citation

Spiegel PB, Bennedsen AR, Claass J, Bruns L, Patterson N, Yiweza D, Schilperoord M. Prevalence of HIV infection in conflict-affected and displaced people in seven sub-Saharan African countries: a systematic review. Lancet. 2007 Jun 30;369(9580):2187-2195. doi: 10.1016/S0140-6736(07)61015-0. — View Citation

Swahn MH, Culbreth R, Salazar LF, Kasirye R, Seeley J. Prevalence of HIV and Associated Risks of Sex Work among Youth in the Slums of Kampala. AIDS Res Treat. 2016;2016:5360180. doi: 10.1155/2016/5360180. Epub 2016 Apr 28. — View Citation

Swahn MH, Palmier JB, Kasirye R, Yao H. Correlates of suicide ideation and attempt among youth living in the slums of Kampala. Int J Environ Res Public Health. 2012 Feb;9(2):596-609. doi: 10.3390/ijerph9020596. Epub 2012 Feb 16. — View Citation

Tekle-Haimanot R, Preux PM, Gerard D, Worku DK, Belay HD, Gebrewold MA. Impact of an educational comic book on epilepsy-related knowledge, awareness, and attitudes among school children in Ethiopia. Epilepsy Behav. 2016 Aug;61:218-223. doi: 10.1016/j.yebeh.2016.05.002. Epub 2016 Jul 1. — View Citation

Towey F. Conference: Comics and medicine. Lancet Oncol. 2014 Aug;15(9):927-8. doi: 10.1016/s1470-2045(14)70352-3. No abstract available. — View Citation

Twimukye A, Bwanika Naggirinya A, Parkes-Ratanshi R, Kasirye R, Kiragga A, Castelnuovo B, Wasswa J, Nabaggala MS, Katabira E, Lamorde M, King RL. Acceptability of a Mobile Phone Support Tool (Call for Life Uganda) for Promoting Adherence to Antiretroviral Therapy Among Young Adults in a Randomized Controlled Trial: Exploratory Qualitative Study. JMIR Mhealth Uhealth. 2021 Jun 14;9(6):e17418. doi: 10.2196/17418. — View Citation

Unger JB, Cabassa LJ, Molina GB, Contreras S, Baron M. Evaluation of a fotonovela to increase depression knowledge and reduce stigma among Hispanic adults. J Immigr Minor Health. 2013 Apr;15(2):398-406. doi: 10.1007/s10903-012-9623-5. — View Citation

Vujcich D, Thomas J, Crawford K, Ward J. Indigenous Youth Peer-Led Health Promotion in Canada, New Zealand, Australia, and the United States: A Systematic Review of the Approaches, Study Designs, and Effectiveness. Front Public Health. 2018 Feb 13;6:31. doi: 10.3389/fpubh.2018.00031. eCollection 2018. — View Citation

Waite M. Writing medical comics. J Vis Commun Med. 2019 Jul;42(3):144-150. doi: 10.1080/17453054.2019.1575641. Epub 2019 Aug 8. — View Citation

Warren E, Post N, Hossain M, Blanchet K, Roberts B. Systematic review of the evidence on the effectiveness of sexual and reproductive health interventions in humanitarian crises. BMJ Open. 2015 Dec 18;5(12):e008226. doi: 10.1136/bmjopen-2015-008226. — View Citation

* Note: There are 50 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants engaged in HIV testing The primary outcome measured in this trial is routine (every 3 months) HIV testing uptake as a measure of HIV prevention. Participants will be asked to self-report when their last HIV test occurred and where it was received (i.e., HIVST, clinic, point-of-care). Every 3 months
Secondary Number of participants with knowledge of their HIV status Since HIV status is self-reported, the investigators will use multiple steps to overcome challenges of social desirability bias. First, interviewers will ask participants to report their current HIV status at 3- and 6-month follow-up. Second, the trained interviewer will offer participants a voluntary rapid HIV test (Alere). Knowledge of HIV status will be assessed as correct for participants who agree to take the rapid test and correctly report their HIV status. The investigators will also record if participants were willing to take the interviewer administered rapid test. 3- and 6-month follow-up
Secondary Number of participants linked to confirmatory HIV testing Participants will be asked if they used their HIVST kit at 3- and 6-month follow-up. For those who affirm use of HIVST kits with a positive test result, the investigators will ask if and where they received a confirmatory test. Participants can receive confirmatory testing without reporting to the interviewer and can submit coupons at MARPI or to local clinics. 3- and 6-month follow-up
Secondary Frequency of linkage to HIV care The investigators will ask participants who seroconvert during the study to report the frequency of HIV care services. In addition, participants can present coupons when accessing MARPI or local clinic services. 3- and 6-month follow-up
Secondary Brief HIV Knowledge Questionnaire The investigators will use the18-item dichotomous response (true/false) to assess HIV Knowledge. A score of 0 is recorded for 'false' responses and 1 for 'true responses. A higher total score indicates better knowledge of HIV. 3- and 6-month follow-up
Secondary Sexual Risk The investigators will assess sexual risk through self-reported measures of consistent condom use (anal, vaginal sex) with regular, causal, and paid sex partners in the past month, as well as the number of sex partners in the past month, condom use self-efficacy, and selling sex in the past 3 months 3- and 6-month follow-up
See also
  Status Clinical Trial Phase
Completed NCT03824353 - Social Intelligence Training in Midlife Phase 2
Not yet recruiting NCT04037579 - Protocol for a Non-randomized Survey in Down Syndrome People Who Practice Sports. Self and Observers´ Perception.
Completed NCT00886171 - Effects of Social Skills and Physical Activity Training on Recreational Activities in Youth N/A
Completed NCT03488927 - Development and Pilot Trial of an Intervention to Reduce Disclosure Recipients Negative Social Reactions and Victims Psychological Distress and Problem Drinking N/A
Completed NCT05162729 - Working Memory and Social-emotional Training for Preschoolers at Risk of ADHD N/A
Completed NCT04478240 - Automating Peer Learning to Reduce Alcohol Use and Related Deviant Behavior in Secondary School N/A
Active, not recruiting NCT04656990 - SKIPping With PAX: An Integrated Gross Motor and Social-Emotional Skill Intervention N/A
Recruiting NCT06101225 - Effects of a Relaxation and Guided Imagery Intervention in School Context N/A
Recruiting NCT04005794 - Virtual Reality Training for Social Skills in Schizophrenia - Comparison With Cognitive Training N/A
Completed NCT06031701 - Neuro-psychosocial Teleassistance for Neuromuscular Diseases N/A
Enrolling by invitation NCT06440460 - Intergenerational Study of War-Affected Youth
Recruiting NCT03873831 - Effects of Therapy Dogs on Social Behavior in Group Social Skills Instruction With Children With Autism N/A
Recruiting NCT05718427 - Effect of ASI on Sensory, Motor, Cognitive, Behavioral Skills and Social Participation in Children With ADHD N/A
Recruiting NCT05791825 - Evaluation of the CHIME Intervention for Improving Early Head Start/Head Start Educator Well-being N/A
Completed NCT03622138 - The Impact Integrated Data System for Quality and Outcomes Tracking of Prevention Programs N/A
Terminated NCT03968081 - Exploration of Theory of Mind in a Situation of Social Rejection in Borderline Personality Disorder N/A
Completed NCT03336190 - Blue Star Cares: Innovative Approaches to Helping Military-Connected Caregivers N/A
Completed NCT03625297 - Shelter Cat Adoption in Families of Children With Autism (Feline Friends) N/A
Completed NCT04159506 - Feasibility and Acceptability Off The Equus Effect N/A
Recruiting NCT05077371 - Peer Support Program in Cancer Patients Elkar Laguntza N/A