HIVNCT03848728
Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa
A study testing SEARCH Youth combination intervention in people with HIV, run by University of California, San Francisco at 2 sites in 2 countries.
Trial summary
The goal of this study is to evaluate the effect of a combination intervention on long-term HIV viral load (VL) suppression among HIV-infected adolescents and young adults 15-24 years of age. The study will take place in 28 rural HIV clinics in western Kenya and southwest Uganda. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- HIV
- What is being tested?
- SEARCH Youth combination intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,988 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Mar 2019to 23 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV infection diagnosed according to country testing guidelines
- Age 15-24 years
- Enrolled in care in a study clinic
- Ability and willingness to provide informed consent
Who cannot join
- None
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The goal of this study is to evaluate the effect of a combination intervention on long-term HIV viral load (VL) suppression among HIV-infected adolescents and young adults 15-24 years of age. The study will take place in 28 rural HIV clinics in western Kenya and southwest Uganda. Clinics will be randomly chosen to either continue to provide study participants standard care or to provide the study intervention, which consists of discussion and counseling on major issues or life events, flexible access to the clinic, and rapid turnaround of VL test results. Participants will take part in the study for at least 2 years.
Read the detailed description
The randomized controlled trial (RCT) will evaluate the effect of the SEARCH Youth intervention on long-term HIV viral load suppression among HIV-infected adolescents/young adults. The study's intervention is based on the PRECEDE model of behavioral change that is targeted towards adolescent and young adult behavior. The study design is a cluster-randomized trial where the unit of randomization is the HIV clinic: 14 clinics randomized to the intervention and 14 to the optimized country standard of care (Differentiated ART care, standard clinic hours, routine VL monitoring, access to 2nd and 3rd line ART), balanced within country. The target enrollment for the intervention is approximately 2300 (50-100 adolescents/young adults with HIV in each clinic, plus family members, providers and others taking part in qualitative interviews).
Community-tailored youth testing and linkage strategies for ART will be implemented to recruit youth for the SEARCH Youth combination intervention RCT. Strategies to reach youth at the highest risk of HIV infection will be implemented. Those individuals who test HIV-positive will be referred to the local clinic for HIV treatment services and, if they otherwise meet entry criteria, to the SEARCH Youth study for possible inclusion.
The components of the SEARCH Youth intervention include:
- Administration of life-stage assessment tool at the beginning of each visit that links to life-stage specific actions and puts subsequent medical discussions into an appropriate context
- Structured choice clinic access which will provide a choice to schedule visits during or after routine clinic hours or in an alternate location, with some phone-only visits available between in-person visits
- Rapid feedback of VL results, by phone or in person, aiming to be provided within 72 hours, to provide immediate feedback on HIV suppression and engage participants in their overall health
- Provider e-collaboratives that comprises of chat groups using WhatsApp or similar secure messaging applications to solicit input about challenging cases using de-identified information
Participants will take part in the study for at least 2 years.
Some participants, family members, providers, HIV-negative youth and key informants will also take part in qualitative interview guides. Costs of the SEARCH Youth intervention will be evaluated to assess its efficiency and cost-effectiveness including as cost per participant, cost per additional participant with viral suppression and cost per DALY gained.
- Conditions
- HIV
- Being tested
- SEARCH Youth combination intervention
- Keywords
- HIV, Adolescent, Young Adult, Viral Load, Counseling, Costs and Cost Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEARCH Youth combination interventionOther
- Administration of life-stage assessment tool
- Structured choice clinic access
- Rapid feedback of VL results
- Provider e-collaboratives with chat groups for discussions of challenging cases using de-identified information
| Study group | Role | What they receive |
|---|---|---|
| Intervention Clinics | Experimental | SEARCH Youth combination intervention, which includes life-stage assessment and counseling, rapid VL feedback, structured choice clinic access, and e-collaboratives chat-based discussion among providers Receives: Other: SEARCH Youth combination intervention |
| Control Clinics | No intervention | Optimized country standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of SEARCH Youth Intervention
Percentage of study participants with virologic suppression (HIV RNA <400 c/mL) at 2 years of follow-up. Mean was calculated as the average percentage across the clusters (clinics)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start14 Mar 2019
- Primary completion23 Jun 2023
- Study completion23 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized trial
- Masking
- None (open label)
- Enrolment
- 1,988 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Infectious Diseases Research Collaboration, Uganda, Kenya Medical Research Institute, Makerere University
- Responsible party
- Sponsor
- Investigators
- Diane V Havlir, MD, Principal investigator, University of California, San FranciscoMoses R Kamya, MBChB, MMed, PhD, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848728
- Sponsor's protocol ID
- SEARCH Youth
- Other IDs
- UG3HD096915, UH3HD096915
- Status last verified
- Sep 2024
- First submitted
- 19 Feb 2019
- Last updated
- 23 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lamb MR, Fayorsey R, Nuwagaba-Biribonwoha H, Viola V, Mutabazi V, Alwar T, Casalini C, Elul B. High attrition before and after ART initiation among youth (15-24 years of age) enrolled in HIV care. AIDS. 2014 Feb 20;28(4):559-68. doi: 10.1097/QAD.0000000000000054.
PubMed 24076661Evans D, Menezes C, Mahomed K, Macdonald P, Untiedt S, Levin L, Jaffray I, Bhana N, Firnhaber C, Maskew M. Treatment outcomes of HIV-infected adolescents attending public-sector HIV clinics across Gauteng and Mpumalanga, South Africa. AIDS Res Hum Retroviruses. 2013 Jun;29(6):892-900. doi: 10.1089/AID.2012.0215. Epub 2013 Feb 25.
PubMed 23373540Nachega JB, Hislop M, Nguyen H, Dowdy DW, Chaisson RE, Regensberg L, Cotton M, Maartens G. Antiretroviral therapy adherence, virologic and immunologic outcomes in adolescents compared with adults in southern Africa. J Acquir Immune Defic Syndr. 2009 May 1;51(1):65-71. doi: 10.1097/QAI.0b013e318199072e.
PubMed 19282780Jobanputra K, Parker LA, Azih C, Okello V, Maphalala G, Kershberger B, Khogali M, Lujan J, Antierens A, Teck R, Ellman T, Kosgei R, Reid T. Factors associated with virological failure and suppression after enhanced adherence counselling, in children, adolescents and adults on antiretroviral therapy for HIV in Swaziland. PLoS One. 2015 Feb 19;10(2):e0116144. doi: 10.1371/journal.pone.0116144. eCollection 2015.
PubMed 25695494Zurcher K, Mooser A, Anderegg N, Tymejczyk O, Couvillon MJ, Nash D, Egger M; IeDEA and MESH consortia. Outcomes of HIV-positive patients lost to follow-up in African treatment programmes. Trop Med Int Health. 2017 Apr;22(4):375-387. doi: 10.1111/tmi.12843. Epub 2017 Feb 20.
PubMed 28102610Massaquoi M, Zachariah R, Manzi M, Pasulani O, Misindi D, Mwagomba B, Bauernfeind A, Harries AD. Patient retention and attrition on antiretroviral treatment at district level in rural Malawi. Trans R Soc Trop Med Hyg. 2009 Jun;103(6):594-600. doi: 10.1016/j.trstmh.2009.02.012. Epub 2009 Mar 18.
PubMed 19298993Ruel T, Mwangwa F, Balzer LB, Ayieko J, Nyabuti M, Mugoma WE, Kabami J, Kamugisha B, Black D, Nzarubara B, Opel F, Schrom J, Agengo G, Nakigudde J, Atuhaire HN, Schwab J, Peng J, Camlin C, Shade SB, Bukusi E, Kapogiannis BG, Charlebois E, Kamya MR, Havlir D. A multilevel health system intervention for virological suppression in adolescents and young adults living with HIV in rural Kenya and Uganda (SEARCH-Youth): a cluster randomised trial. Lancet HIV. 2023 Aug;10(8):e518-e527. doi: 10.1016/S2352-3018(23)00118-2.
PubMed 37541706Johnson-Peretz J, Lebu S, Akatukwasa C, Getahun M, Ruel T, Lee J, Ayieko J, Mwangwa F, Owino L, Onyango A, Maeri I, Atwine F, Charlebois ED, Bukusi EA, Kamya MR, Havlir DV, Camlin CS. "I was still very young": agency, stigma and HIV care strategies at school, baseline results of a qualitative study among youth in rural Kenya and Uganda. J Int AIDS Soc. 2022 Jul;25 Suppl 1(Suppl 1):e25919. doi: 10.1002/jia2.25919.
PubMed 35818888Mwangwa F, Charlebois ED, Ayieko J, Olio W, Black D, Peng J, Kwarisiima D, Kabami J, Balzer LB, Petersen ML, Kapogiannis B, Kamya MR, Havlir DV, Ruel TD. Two or more significant life-events in 6-months are associated with lower rates of HIV treatment and virologic suppression among youth with HIV in Uganda and Kenya. AIDS Care. 2023 Jan;35(1):95-105. doi: 10.1080/09540121.2022.2052260. Epub 2022 May 16.
PubMed 35578398
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa
- ClinicalTrials.gov ID
- NCT03848728
- Acronym / sponsor ID
- SEARCH Youth
- Conditions
- HIV
- Keywords
- HIV, Adolescent, Young Adult, Viral Load, Counseling, Costs and Cost Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,988 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Infectious Diseases Research Collaboration, Uganda, Kenya Medical Research Institute, Makerere University
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Posted 23 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the effect of a combination intervention on long-term HIV viral load (VL) suppression among HIV-infected adolescents and young adults 15-24 years of age. The study will take place in 28 rural HIV clinics in western Kenya and southwest Uganda. Clinics will be randomly chosen to either continue to provide study participants standard care or to provide the study intervention, which consists of discussion and counseling on major issues or life events, flexible access to the clinic, and rapid turnaround of VL test results. Participants will take part in the study for at least 2 years.
Detailed description
The randomized controlled trial (RCT) will evaluate the effect of the SEARCH Youth intervention on long-term HIV viral load suppression among HIV-infected adolescents/young adults. The study's intervention is based on the PRECEDE model of behavioral change that is targeted towards adolescent and young adult behavior. The study design is a cluster-randomized trial where the unit of randomization is the HIV clinic: 14 clinics randomized to the intervention and 14 to the optimized country standard of care (Differentiated ART care, standard clinic hours, routine VL monitoring, access to 2nd and 3rd line ART), balanced within country. The target enrollment for the intervention is approximately 2300 (50-100 adolescents/young adults with HIV in each clinic, plus family members, providers and others taking part in qualitative interviews).
Community-tailored youth testing and linkage strategies for ART will be implemented to recruit youth for the SEARCH Youth combination intervention RCT. Strategies to reach youth at the highest risk of HIV infection will be implemented. Those individuals who test HIV-positive will be referred to the local clinic for HIV treatment services and, if they otherwise meet entry criteria, to the SEARCH Youth study for possible inclusion.
The components of the SEARCH Youth intervention include:
- Administration of life-stage assessment tool at the beginning of each visit that links to life-stage specific actions and puts subsequent medical discussions into an appropriate context
- Structured choice clinic access which will provide a choice to schedule visits during or after routine clinic hours or in an alternate location, with some phone-only visits available between in-person visits
- Rapid feedback of VL results, by phone or in person, aiming to be provided within 72 hours, to provide immediate feedback on HIV suppression and engage participants in their overall health
- Provider e-collaboratives that comprises of chat groups using WhatsApp or similar secure messaging applications to solicit input about challenging cases using de-identified information
Participants will take part in the study for at least 2 years.
Some participants, family members, providers, HIV-negative youth and key informants will also take part in qualitative interview guides. Costs of the SEARCH Youth intervention will be evaluated to assess its efficiency and cost-effectiveness including as cost per participant, cost per additional participant with viral suppression and cost per DALY gained.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Clinics | Experimental | Other: SEARCH Youth combination interventionSEARCH Youth combination intervention, which includes life-stage assessment and counseling, rapid VL feedback, structured choice clinic access, and e-collaboratives chat-based discussion among providers |
| Control Clinics | No intervention | –Optimized country standard of care |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- HIV infection diagnosed according to country testing guidelines
- Age 15-24 years
- Enrolled in care in a study clinic
- Ability and willingness to provide informed consent
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| SEARCH Youth combination intervention* Administration of life-stage assessment tool * Structured choice clinic access * Rapid feedback of VL results * Provider e-collaboratives with chat groups for discussions of challenging cases using de-identified information | Other | Intervention Clinics |
Primary outcome
Effectiveness of SEARCH Youth Intervention
Time frame: 2 years
Percentage of study participants with virologic suppression (HIV RNA <400 c/mL) at 2 years of follow-up. Mean was calculated as the average percentage across the clusters (clinics)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24076661Lamb MR, Fayorsey R, Nuwagaba-Biribonwoha H, Viola V, Mutabazi V, Alwar T, Casalini C, Elul B. High attrition before and after ART initiation among youth (15-24 years of age) enrolled in HIV care. AIDS. 2014 Feb 20;28(4):559-68. doi: 10.1097/QAD.0000000000000054.
- Background: PubMed 23373540Evans D, Menezes C, Mahomed K, Macdonald P, Untiedt S, Levin L, Jaffray I, Bhana N, Firnhaber C, Maskew M. Treatment outcomes of HIV-infected adolescents attending public-sector HIV clinics across Gauteng and Mpumalanga, South Africa. AIDS Res Hum Retroviruses. 2013 Jun;29(6):892-900. doi: 10.1089/AID.2012.0215. Epub 2013 Feb 25.
- Background: PubMed 19282780Nachega JB, Hislop M, Nguyen H, Dowdy DW, Chaisson RE, Regensberg L, Cotton M, Maartens G. Antiretroviral therapy adherence, virologic and immunologic outcomes in adolescents compared with adults in southern Africa. J Acquir Immune Defic Syndr. 2009 May 1;51(1):65-71. doi: 10.1097/QAI.0b013e318199072e.
- Background: PubMed 25695494Jobanputra K, Parker LA, Azih C, Okello V, Maphalala G, Kershberger B, Khogali M, Lujan J, Antierens A, Teck R, Ellman T, Kosgei R, Reid T. Factors associated with virological failure and suppression after enhanced adherence counselling, in children, adolescents and adults on antiretroviral therapy for HIV in Swaziland. PLoS One. 2015 Feb 19;10(2):e0116144. doi: 10.1371/journal.pone.0116144. eCollection 2015.
- Background: PubMed 28102610Zurcher K, Mooser A, Anderegg N, Tymejczyk O, Couvillon MJ, Nash D, Egger M; IeDEA and MESH consortia. Outcomes of HIV-positive patients lost to follow-up in African treatment programmes. Trop Med Int Health. 2017 Apr;22(4):375-387. doi: 10.1111/tmi.12843. Epub 2017 Feb 20.
- Background: PubMed 19298993Massaquoi M, Zachariah R, Manzi M, Pasulani O, Misindi D, Mwagomba B, Bauernfeind A, Harries AD. Patient retention and attrition on antiretroviral treatment at district level in rural Malawi. Trans R Soc Trop Med Hyg. 2009 Jun;103(6):594-600. doi: 10.1016/j.trstmh.2009.02.012. Epub 2009 Mar 18.
- Derived from this study: PubMed 37541706Ruel T, Mwangwa F, Balzer LB, Ayieko J, Nyabuti M, Mugoma WE, Kabami J, Kamugisha B, Black D, Nzarubara B, Opel F, Schrom J, Agengo G, Nakigudde J, Atuhaire HN, Schwab J, Peng J, Camlin C, Shade SB, Bukusi E, Kapogiannis BG, Charlebois E, Kamya MR, Havlir D. A multilevel health system intervention for virological suppression in adolescents and young adults living with HIV in rural Kenya and Uganda (SEARCH-Youth): a cluster randomised trial. Lancet HIV. 2023 Aug;10(8):e518-e527. doi: 10.1016/S2352-3018(23)00118-2.
- Derived from this study: PubMed 35818888Johnson-Peretz J, Lebu S, Akatukwasa C, Getahun M, Ruel T, Lee J, Ayieko J, Mwangwa F, Owino L, Onyango A, Maeri I, Atwine F, Charlebois ED, Bukusi EA, Kamya MR, Havlir DV, Camlin CS. "I was still very young": agency, stigma and HIV care strategies at school, baseline results of a qualitative study among youth in rural Kenya and Uganda. J Int AIDS Soc. 2022 Jul;25 Suppl 1(Suppl 1):e25919. doi: 10.1002/jia2.25919.
- Derived from this study: PubMed 35578398Mwangwa F, Charlebois ED, Ayieko J, Olio W, Black D, Peng J, Kwarisiima D, Kabami J, Balzer LB, Petersen ML, Kapogiannis B, Kamya MR, Havlir DV, Ruel TD. Two or more significant life-events in 6-months are associated with lower rates of HIV treatment and virologic suppression among youth with HIV in Uganda and Kenya. AIDS Care. 2023 Jan;35(1):95-105. doi: 10.1080/09540121.2022.2052260. Epub 2022 May 16.
- Individual participant dataSharing planned: No
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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.
Diane V Havlir, MD principal investigator
University of California, San Francisco
Moses R Kamya, MBChB, MMed, PhD principal investigator
Makerere University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEARCH Youth combination intervention in people with HIV, run by University of California, San Francisco at 2 sites in 2 countries.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya, Uganda. 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?
Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of SEARCH Youth Intervention (time frame: 2 years). 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 NCT03848728, 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 23 Oct 2024.