HIV Testing Clinical Trial
Official title:
Caregiver-Assisted Oral Fluid-based HIV Screening in Children: Estimation of Acceptability, Feasibility and Effectiveness Linked to Index Testing Services in Zambia
Verified date | February 2022 |
Source | Catholic Relief Services |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to evaluate the acceptability, feasibility and effectiveness of a caregiver-assisted oral fluid-based HIV test to screen children for HIV in Zambia. The results of this study are intended to support expanded access to HIV testing and treatment services for children, and to ensure that all newly diagnosed children are linked to clinical care.
Status | Completed |
Enrollment | 2730 |
Est. completion date | December 8, 2021 |
Est. primary completion date | December 8, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria for adult index parent/caregivers: - All HIV-positive adults - 18 years old or older with eligible children Inclusion Criteria for Eligible children: • All biological children (of an adult index case) 18 months - 14 years of age with an unknown HIV status Exclusion Criteria for adult index parent/caregivers: - Adults answering "yes" to any of the four intimate partner violence risk assessment questions - Adults previously diagnosed as mentally disabled - Adults currently in prison are excluded from this study. - Adult partners of index parent/caregivers Exclusion Criteria for Children: - Children <18 months of age - All biological children (of an index case) 18 months - 14 years of age with a documented HIV-negative status after cessation of breastfeeding - All biological children (of an index case) 18 months - 14 years of age with a documented HIV-positive status - Children still breastfeeding or with cessation of breastfeeding < 3 months - Non-biological children of the index parent/caregiver |
Country | Name | City | State |
---|---|---|---|
Zambia | Nadezwe Rural Health Center | Chikankata | Southern |
Zambia | Chivuna Rural Health Centre | Livingstone | Southern |
Zambia | Chazanga Clinic | Lusaka | |
Zambia | Chilanga Clinic | Lusaka | |
Zambia | Chilenje Clinic | Lusaka | |
Zambia | Kalingalinga Clinic | Lusaka | |
Zambia | Kazimva Rural Health Clinic | Lusaka | |
Zambia | Matero Clinic | Lusaka | |
Zambia | Nan'gongwe Clinic | Lusaka | |
Zambia | Shimabala Rural Health Centre | Lusaka | |
Zambia | Munenga Rural Health Centre | Mazabuka | Southern |
Zambia | Keemba Rural Health Centre | Monze | Southern |
Zambia | Manungu Rural Health Centre | Monze | Southern |
Zambia | Mutendere Clinic | Mutendere | Lusaka |
Zambia | Chitope Rural Health Centre | Mwavi | Lusaka |
Lead Sponsor | Collaborator |
---|---|
Catholic Relief Services | Centers for Disease Control and Prevention |
Zambia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Estimate the acceptability of implementing caregiver-assisted oral fluid-based HIV screening fluid-based HIV screening for children as a part of index testing services for index parent/caregivers. | Proportion of eligible index parent/caregivers (disaggregated by sex) that accepted an oral fluid-based HIV screening kit as part of innovative index testing services for their eligible children when first offered.
Proportion of eligible index parent/caregivers (disaggregated by sex) that accepted an oral fluid-based HIV screening kit as part of innovative index testing services for their eligible children when they returned for a subsequent visit. Proportion of eligible children (i.e. unknown HIV status) screened with an oral fluid-based HIV screening kit. |
6 months | |
Primary | Estimate the feasibility of implementing caregiver-assisted oral fluid-based HIV screening fluid-based HIV screening for children as part of index testing services for HIV-positive adults. | Proportion of index parent/caregivers who reported that the caregiver-assisted oral fluid-based HIV screening kit to screen children for HIV was easy to use.
Proportion of index parent/caregivers who reported needing additional assistance with administering the oral fluid-based HIV screening kit. Proportion of index parent/caregivers who reported adverse events related to the use of caregiver-assisted oral fluid-based HIV screening kits to screen their children for HIV. |
6 months | |
Primary | Estimate the effectiveness of caregiver-assisted oral fluid-based HIV screening on testing yield, return to clinic, and linkage to ART for newly identified CLHIV. | Proportion of eligible children screened reactive through a caregiver-assisted oral fluid-based HIV screening kit.
Proportion of eligible children who screened reactive through a caregiver-assisted oral fluid-based HIV screening kit who received confirmatory testing, within 1 day, 1 week, 1 month of their reactive screen. Proportion of eligible children who screened reactive through a caregiver-assisted oral fluid-based HIV screening kit who started on ART within 1 day, 1 week, 1 month of their confirmatory test. Proportion of index parent/caregivers who were offered an oral fluid-based test kit to screen their eligible children for HIV used it. |
6 months | |
Secondary | Estimate the cost of caregiver-assisted oral fluid-based HIV screening compared to the existing standard costs of the existing referral to testing program. | • Comparative costs between oral fluid-based screening and the costs of the existing referral to testing program, from the perspective of the health care provider. | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04033718 -
Inpatient Package to Reduce HIV and AIDS-related Death in Zambia
|
N/A | |
Withdrawn |
NCT03938077 -
A Community-University Approach to Preventing HIV
|
N/A | |
Recruiting |
NCT05615935 -
Experiential HIV Testing Increasing Testing Related Knowledge and Practice, and Reduce Stigma Toward HIV of Nurses.
|
N/A | |
Active, not recruiting |
NCT06150937 -
HST for Female Sex Workers/Drug Users in Kazakhstan
|
N/A | |
Completed |
NCT01637324 -
Multidisciplinary Services to Enhance HIV Testing and Linkage to Care Among MSM
|
N/A | |
Completed |
NCT05388084 -
Peer Led Outreach to Engage Male Partners of Pregnant Women in Uganda (Okutuuka Study)
|
N/A | |
Active, not recruiting |
NCT05306938 -
Adolescent Wellness Visits in Tanzania
|
N/A | |
Recruiting |
NCT05384145 -
Implementation Trial to Evaluate a Population Health Combination Intervention to Meet HIV Testing, Linkage, and Viral Suppression Goals in Alabama
|
N/A | |
Recruiting |
NCT05020353 -
OraQuick® HIV Self-Test Study in Canada
|
N/A | |
Active, not recruiting |
NCT02834572 -
Using Technology to Match Young Black Men and Transwomen Who Have Sex With Men or Transwomen to HIV Testing Options
|
N/A | |
Completed |
NCT04210271 -
Testing an Intervention to Increase HIV Self-Testing Among Young, Black MSM
|
N/A | |
Active, not recruiting |
NCT04810559 -
Near Patient Study of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in Oral Fluid and Fingerstick Whole Blood
|
N/A | |
Completed |
NCT03939455 -
Mobile Augmented Screening Tool to Increase Adolescent HIV Testing and Linkage to Care
|
N/A | |
Not yet recruiting |
NCT02154802 -
Increasing HIV Testing in Urban Emergency Departments Via Mobile Technology
|
N/A | |
Completed |
NCT05685498 -
Peer-led HIV Self-testing Among Men in Two Ugandan Fishing Communities
|
N/A | |
Recruiting |
NCT04030689 -
Free HIV Testing in Private Biological Laboratories: A New Offer to Encourage HIV Testing
|
||
Completed |
NCT02714140 -
Does Preference-based HIV Testing Increase Uptake in High Risk Populations?
|
N/A | |
Completed |
NCT05107401 -
Crowdsourcing to Reduce HIV Stigma Among Adolescents and Young Adults in Kazakhstan
|
N/A | |
Completed |
NCT01760057 -
Evaluating the Effect of a Novel Web-based Intervention to Increase HIV Testing in Men Who Have Sex With Men
|
N/A | |
Recruiting |
NCT03757104 -
Home-based Intervention to Test and Start
|
N/A |