NCT03024762

Brief Summary

The Active Search for Pediatric HIV/AIDS (ASPA) aims at assessing the acceptability, feasibility and effectiveness of the targeted provider-initiated-testing and counseling (tPITC) in comparison with the blanket provider-initiated-testing and counseling (bPITC) among children and adolescents in Cameroon. The new knowledge generated will inform programming of more suitable strategies to identify HIV-infected children and adolescents and this will contribute to reducing the current global gap in HIV treatment among this subpopulation group.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
870

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

December 6, 2016

Last Update Submit

January 22, 2017

Conditions

Pediatric HIV Infection

Outcome Measures

Primary Outcomes (1)

  • Yield

    Proportion of newly identified HIV cases amongst all children and adolescents eligible for HIV testing 2. Prevalence: proportion of HIV cases amongst children tested

    6 months

Secondary Outcomes (6)

  • Prevalence

    6 months

  • Linkage

    6 months

  • Combined effect (tPITC+bPITC)

    6 months

  • Acceptability

    6 months

  • feasibility

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL

The intervention arm involves children and adolescents with unknown HIV status, aged between 6 weeks to 19 years, born to parents living with HIV/AIDS. These children will be identified for HIV testing through their parents diagnosed with HIV or receiving HIV care in the hospital.

Procedure: targeted Provider-Initiated-Testing and Counseling (tPITC)

Control arm

NO INTERVENTION

The control arm involves children and adolescents with unknown HIV status, aged between 6 weeks to 19 years; consulting in the hospital for any motive. These children will be recruited for HIV testing at the outpatient department (OPD) and this through their accompany parents/guardians. Care providers will be advised to propose HIV testing systematically to all children and adolescents showing up at the OPD irrespective of the chief complaint.

Interventions

targeted Provider-Initiated-Testing and Counseling (tPITC)PROCEDURE

The intervention arm involves children and adolescents with unknown HIV status, aged between 6 weeks to 19 years, born to parents living with HIV/AIDS. These children will be identified for HIV testing through their parents diagnosed with HIV or receiving HIV care in the hospital.

Intervention arm

Eligibility Criteria

Age6 Weeks - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • HIV-infected parents: Parents diagnosed with HIV infection or receiving HIV services in the hospital and consenting to participate will be eligible for enrollment in the study.
  • Parents/guardians seeking care for their children in the hospital: Parents/guardians presenting at the hospital with sick children will be enrolled in the study irrespective of the motive of consultations for their children.
  • Children of HIV infected parents: children of HIV infected parents aged between 6 weeks to 19 years old will be eligible for enrollment in the study. Parents/guardians consent will be required as well as assent of older kids.
  • Children consulting in the hospital: Children aged 6 weeks to 19 years old consulting in the hospital for any reason will be eligible to participate in the study. Parents/guardians consent will be required as well as assent of older kids.
  • HIV infected children: children (6weeks\<years\<19 years old) enrolled in HIV care in the hospital at least 2 years before the beginning of the project and after this beginning will be enrolled into the study to assess retention into care and factors associated with loss to follow up.
  • Health personnel: Health personnel involved in children's consultations and consenting to participate will be enrolled in the study.

You may not qualify if:

  • Refusal to participate: health personnel, parents/guardians, children not willing to participate will be excluded from the study
  • HIV Status: Children with known HIV positive status will be excluded for HIV testing
  • Age: Children below the age of 6 weeks or above 19 years will be excluded from the study
  • Health conditions: parents who are critically ill or mentally unstable will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Abong-Mbang District Hospital

Abong Mbang, East Region, Cameroon

Location

Ndop District Hospital

Ndop, North-West Region, Cameroon

Location

Limbe Regional Hospital

Limbe, Cameroon

Location

Related Publications (2)

  • Yumo HA, Ajeh RA, Sieleunou I, Ndenkeh JN Jr, Jordan MR, Sam-Agudu NA, Kuaban C, Loescher T. Parental and child-level predictors of HIV testing uptake, seropositivity and treatment initiation among children and adolescents in Cameroon. PLoS One. 2020 Apr 13;15(4):e0230988. doi: 10.1371/journal.pone.0230988. eCollection 2020.

    PMID: 32282808DERIVED

  • Yumo HA, Kuaban C, Ajeh RA, Nji AM, Nash D, Kathryn A, Beissner M, Loescher T. Active case finding: comparison of the acceptability, feasibility and effectiveness of targeted versus blanket provider-initiated-testing and counseling of HIV among children and adolescents in Cameroon. BMC Pediatr. 2018 Sep 25;18(1):309. doi: 10.1186/s12887-018-1276-7.

    PMID: 30253758DERIVED

Related Links

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Habakkuk Yumo, MD, MPH

    Research for Development International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The intervention assessed is the targeted Provider-Initiated Testing and Counselling (tPITC) whereby HIV positive parents receiving HIV services in the hospital are invited to have their children of unknown HIV status tested for HIV. The control arm is the blanket Provider-Initiated Testing and Counselling (bPITC) whereby all children consulting in the hospital (and with unknown HIV status) are invited to test for HIV and this irrespective of the presenting complaint. The study is assessing in the same hospital the effectiveness of tPITC vs bPITC.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Yumo, Habakkuk Azinyui, MD, MPH

Study Record Dates

First Submitted

December 6, 2016

First Posted

January 19, 2017

Study Start

July 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2018

Last Updated

January 24, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

Data can be made available to other researchers through an application addressed to the sponsor (Research for Development International) and this via the Principal Investigator (Dr Yumo Habakkuk).

Locations

CA(3)