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Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa

Strategic Antiretroviral Therapy and HIV Testing for Youth in Rural Africa

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03848728
Enrollment
1988
Registered
2019-02-21
Start date
2019-03-14
Completion date
2023-06-23
Last updated
2024-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV, Adolescent, Young Adult, Viral Load, Counseling, Costs and Cost Analysis

Brief 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. 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.

Interventions

OTHERSEARCH 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

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Infectious Diseases Research Collaboration, Uganda
CollaboratorOTHER
Kenya Medical Research Institute
CollaboratorOTHER
Makerere University
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Cluster-randomized trial

Eligibility

Sex/Gender
ALL
Age
15 Years to 24 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of SEARCH Youth Intervention2 yearsPercentage 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)

Countries

Kenya, Uganda

Participant flow

Participants by arm

ArmCount
Intervention Clinics
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 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 Information presented for participants included in primary analysis.
785
Control Clinics
Optimized country standard of care. Information presented for participants included in primary analysis.
764
Total1,549

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath1613
Overall StudyOutmigrated to non-study community98106
Overall StudyTransfered to non-study clinic3248
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicTotalControl ClinicsIntervention Clinics
Age, Customized
Median age
21 years21 years21 years
Antiretroviral regimen at enrolment
ABC-3TC-EFV
23 Participants11 Participants12 Participants
Antiretroviral regimen at enrolment
AZT-3TC-ATV/r
26 Participants14 Participants12 Participants
Antiretroviral regimen at enrolment
AZT-3TC-NVP
75 Participants42 Participants33 Participants
Antiretroviral regimen at enrolment
Other
81 Participants42 Participants39 Participants
Antiretroviral regimen at enrolment
TDF-3TC-ATV/r
28 Participants18 Participants10 Participants
Antiretroviral regimen at enrolment
TDF-3TC-DTG
182 Participants101 Participants81 Participants
Antiretroviral regimen at enrolment
TDF-3TC-EFV
1118 Participants527 Participants591 Participants
Baseline care status
Engaged - started treatment > 6 months before enrolment with HIV care visit within 6 months
1026 Participants530 Participants496 Participants
Baseline care status
Recently engaged - started treatment within 6 months of enrolment
466 Participants214 Participants252 Participants
Baseline care status
Re-engaging - started treatment > than 6 months before enrolment, no HIV care visit within 6 months
55 Participants19 Participants36 Participants
Baseline viral load <400 copies per mL1147 Participants574 Participants573 Participants
Drinks alcohol231 Participants94 Participants137 Participants
Education (started or completed)
At boarding school
112 Participants56 Participants56 Participants
Education (started or completed)
No school
55 Participants24 Participants31 Participants
Education (started or completed)
Primary school
1032 Participants525 Participants507 Participants
Education (started or completed)
Secondary school
369 Participants175 Participants194 Participants
Education (started or completed)
Tertiary school
93 Participants40 Participants53 Participants
Employment status
Employed
591 Participants308 Participants283 Participants
Employment status
In school
320 Participants155 Participants165 Participants
Employment status
Unemployed
638 Participants301 Participants337 Participants
Marital status
Divorced
179 Participants89 Participants90 Participants
Marital status
Married, monogamous
633 Participants327 Participants306 Participants
Marital status
Married, polygamous
95 Participants51 Participants44 Participants
Marital status
Single, never married
633 Participants291 Participants342 Participants
Marital status
Widowed
9 Participants6 Participants3 Participants
Mobile439 Participants229 Participants210 Participants
Number of children
0 children
653 Participants323 Participants330 Participants
Number of children
1 child
485 Participants227 Participants258 Participants
Number of children
2 children
260 Participants131 Participants129 Participants
Number of children
3-5 children
115 Participants64 Participants51 Participants
Race/Ethnicity, Customized
African/Black
1549 Participants764 Participants785 Participants
Region of Enrollment
Kenya
893 participants440 participants453 participants
Region of Enrollment
Uganda
656 participants324 participants332 participants
Sex: Female, Male
Female
1248 Participants605 Participants643 Participants
Sex: Female, Male
Male
301 Participants159 Participants142 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
16 / 1,01213 / 976
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
48 / 1,01213 / 976

Outcome results

Primary

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)

Time frame: 2 years

Population: Study participants at year 2, excluding those who enrolled on/after Dec 1, 2019, transferred care, outmigrated, or withdrew.

ArmMeasureGroupValue (MEAN)
Intervention ClinicsEffectiveness of SEARCH Youth InterventionAll88.2 % of participants
Intervention ClinicsEffectiveness of SEARCH Youth InterventionEngaged90.9 % of participants
Intervention ClinicsEffectiveness of SEARCH Youth InterventionRecently engaged80.1 % of participants
Intervention ClinicsEffectiveness of SEARCH Youth InterventionRe-engaging84.8 % of participants
Control ClinicsEffectiveness of SEARCH Youth InterventionRe-engaging53.2 % of participants
Control ClinicsEffectiveness of SEARCH Youth InterventionAll80.5 % of participants
Control ClinicsEffectiveness of SEARCH Youth InterventionRecently engaged73.5 % of participants
Control ClinicsEffectiveness of SEARCH Youth InterventionEngaged85.3 % of participants
p-value: 0.001995% CI: [1.03, 1.16]TMLE

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026