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Active Search for Pediatric HIV/AIDS (ASPA) (ASPA)

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ClinicalTrials.gov Identifier: NCT03024762
Recruitment Status : Unknown
Verified January 2017 by Dr Yumo, Habakkuk Azinyui, Research for Development International.
Recruitment status was:  Active, not recruiting
First Posted : January 19, 2017
Last Update Posted : January 24, 2017
Sponsor:
Collaborators:
Else Kröner Fresenius Foundation
Albert Einstein College of Medicine
Information provided by (Responsible Party):
Dr Yumo, Habakkuk Azinyui, Research for Development International

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.

Condition or disease Intervention/treatment Phase
Pediatric HIV Infection Procedure: targeted Provider-Initiated-Testing and Counseling (tPITC) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 870 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Active Search for Pediatric HIV/AIDS (ASPA)
Actual Study Start Date : July 2015
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention arm
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)
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.

No Intervention: Control arm
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.



Primary Outcome Measures :
  1. Yield [ Time Frame: 6 months ]
    Proportion of newly identified HIV cases amongst all children and adolescents eligible for HIV testing 2. Prevalence: proportion of HIV cases amongst children tested


Secondary Outcome Measures :
  1. Prevalence [ Time Frame: 6 months ]
    Prevalence: proportion of HIV cases amongst children and adolescents tested for HIV

  2. Linkage [ Time Frame: 6 months ]
    Linkage in care: proportion of pediatric HIV cases linked to care (CD4 testing and/or enrolment on ART)

  3. Combined effect (tPITC+bPITC) [ Time Frame: 6 months ]
    Combined effect of tPITC and bPITC: Number of children tested positive and initiated on ART in the hospital during the study as compared to historical data.

  4. Acceptability [ Time Frame: 6 months ]
    HIV testing acceptance rate: proportion of parents who accepted to have their children tested for HIV. The acceptability assesses the attitude of parents/caregivers to opt in for HIV testing of their children.

  5. feasibility [ Time Frame: 6 months ]
    HIV testing uptake: proportion of children tested amongst all eligible identified through parents in HIV care (for the targeted arm) or amongst all eligible children who visited the hospital (control arm) during the enrolment period. The feasibility outcome variable assesses the capacity of the health facility to routinely test all eligible children

  6. Retention [ Time Frame: 24 months ]
    Retention in care: proportion of cases still in care 12 and 24 months after enrolment



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Ages Eligible for Study:   6 Weeks to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024762


Locations
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Cameroon
Abong-Mbang District Hospital
Abong Mbang, East, Cameroon
Ndop District Hospital
Ndop, North West, Cameroon
Limbe Regional Hospital
Limbe, Cameroon
Sponsors and Collaborators
Research for Development International
Else Kröner Fresenius Foundation
Albert Einstein College of Medicine
Investigators
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Principal Investigator: Habakkuk Yumo, MD, MPH Research for Development International

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Yumo, Habakkuk Azinyui, Dr Yumo, Habakkuk Azinyui, MD, MPH, Research for Development International
ClinicalTrials.gov Identifier: NCT03024762     History of Changes
Other Study ID Numbers: R4D0007/2015
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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).
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases