Orphans and Vulnerable Children Risk Screening Tool Research Study (Zimbabwe)

NCT03343158 | Terminated

• 1 other identifier: EG0174
• Study Type: observational
• Target: 2,260
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators propose to assess the sensitivity, specificity, positive and negative predictive value of an HIV Risk Screening Tool in identifying the risk of being HIV-infected among Orphans and Vulnerable Children (OVC) aged 2-18 years in a community setting.

Conditions

Orphans, Children, Adolescents; Vulnerable Children, Adolescents; Community-based

Outcome Measures

Primary Outcomes (2)

• Phase 1: Validity of various questions in predicting the probability of HIV among OVC (Screening tool)

  Sensitivity and specificity of eleven questions in predicting HIV among OVC

  Four weeks

• Phase 2: Validation of combined questions in predicting HIV among OVC (Validating Screen tool)

  Validation of combined questions assessed from Phase 1 in predicting HIV among OVC

  Six weeks

Secondary Outcomes (1)

• Usability of screening tool

  Two weeks

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

OVC aged 2-18 years, living in households which are registered on a database developed by World Education Institute, a Non-Government Organization which provides services for orphans and vulnerable children in the community

You may qualify if:

• Children/adolescents ages 2 up to 18 years living in a household and enrolled in WEI/Zimbabwe and/or partners program;
• Children/adolescents ages 2 up to 18 years with HIV status unknown, or who tested negative three or more months ago;
• Children/adolescents ages 2 up to 18 years who are healthy or ill (unless they are ill enough to require immediate hospitalization).

You may not qualify if:

• Children/adolescents aged 2 up to 18 years tested HIV positive
• Children/adolescents ages 2 up to 18 years who require immediate hospitalization;
• Children/adolescents ages 2 up to 18 years who refuse/are refused participation.

Sponsors & Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation: lead
• JSI Research & Training Institute, Inc.: collaborator
• Biomedical Research and Training Institute, Zimbabwe: collaborator
• United States Agency for International Development (USAID): collaborator
• World Education, Inc.: collaborator

Study Sites (1)

EGPAF Zimbabwe

Harare, Zimbabwe

Location

Study Officials

• Agnes Mahomva, MD

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

• Godfrey Woelk, PhD

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 17, 2017
• Study Start: October 17, 2017
• Primary Completion: February 28, 2018
• Study Completion: March 31, 2018
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ZI (1)