Assessing the Effectiveness and Feasibility of Voluntary Assisted Partner Notification Services

NCT03944395 | Unknown DMC

• 1 other identifier: VAPN
• Study Type: interventional
• Target: 1,785
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate effectiveness of voluntary assisted partner notification (VAPN) in real-world programmatic settings, a non-randomized, stepped wedge study in high volume facilities in 6 high HIV burden focus districts (Blantyre, Zomba, Chikwawa, Machinga, Mangochi and Lilongwe urban) is proposed. The primary objective is to compare the percentage of contacts tested during the standard of care (SOC) phase (i.e., using passive family referral services (FRS) index testing methodology) with the percentage of contacts tested during the SOC plus VAPN phase, by 1, 2, and 3 months after the initial contact with the index client. Assessment of feasibility will be achieved through documentation of operational lessons learned during implementation. Findings will contribute to ongoing policy discussions whether Malawi should adopt VAPN in its national HIV testing guidelines

Conditions

HIV Infections

Keywords

Active HIV Case finding; Partner Notification Services

Outcome Measures

Primary Outcomes (1)

• Proportion of eligible index clients offered VAPN services

  Number of eligible index clients who are offered VAPN divide by the number of all eligible index clients identified for enrolment

  10 months

Secondary Outcomes (1)

• Proportion of contacts who returned for HIV testing

  10 months

Other Outcomes (1)

• HIV Yield over time

  10 months

Study Arms (1)

Assisted Partner notification services

OTHER

Voluntary assisted partner notification (VAPN) services will be offered at facilities according to a stepped wedge design. Once VAPN services are activated at a facility, HIV positive individuals will be offered four options (3 voluntary assisted partner notification options and 1 standard of care option) for inviting their contacts, which they can choose to accept or decline.

Other: Assisted Partner Notification Services

Interventions

Assisted Partner Notification Services OTHER

Three options for partner Notification services; contract referral, provider referral and dual referral

Assisted Partner notification services

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Index clients:
• All index clients who are 18 years old or older (i.e., new positives, known positives not on treatment, and known positives who are on treatment), will be eligible for the study and eligible to receive VAPN services if informed consent is given.
• Contacts:
• All contacts of any age are eligible to be included in the study and eligible to receive HIV testing services according to Ministry of Health (MOH) guidelines. The age of consent to receive any component of HIV testing services in Malawi is 13. Prior to testing a contact (e.g., a child of an index case) who is \<13 years old, for HIV, the guardian's consent is needed, per MOH guidelines.

You may not qualify if:

• Index clients
• Did not consent
• Aged \<18 years old a
• Prisoners, Mentally disabled
• Intimate partner violence
• Cannot explain the three VAPN options (contract, referral, and dual referral) in a way that would result in true informed assent on the part of the client.
• Contacts:

Sponsors & Collaborators

• Lighthouse Trust: lead
• United States Agency for International Development (USAID): collaborator
• Centers for Disease Control and Prevention: collaborator
• Elizabeth Glaser Pediatric AIDS Foundation: collaborator
• Ministry of Health, Malawi: collaborator

Study Sites (1)

Ministry of Health Facilities

Lilongwe, Malawi

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Hannock Tweya, PhD

CONTACT

+265 1758940; h_tweya@lighthouse.org.mw

Odala Sande, BSc

CONTACT

+265 1758940; o_sande@lighthouse.org.mw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Monitoring, Evaluation and Research

Model Details: A non-randomized, pragmatic, stepped-wedge study to be implemented in 80 Sites. The stepped wedge portion of the study will last 10 months (May - March 2018). Once all 80 sites are implementing standard of care (SOC) plus VAPN, the study will be extended an additional 3 months to assess any trends in declining yield from SOC plus VAPN index case testing services.

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: May 9, 2019
• Study Start: May 21, 2018
• Primary Completion: April 29, 2020
• Study Completion: April 29, 2020
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

MA (1)