Assessing the Effectiveness and Feasibility of Voluntary Assisted Partner Notification Services

NCT ID: NCT03944395

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1785 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-21
• Study Completion Date: 2020-04-29

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

Detailed Description

The over-arching goal of this study is to evaluate the effectiveness and feasibility of the voluntary assisted partner notification (VAPN) intervention in real-world programmatic settings in high burden facilities in 6 priority districts in Malawi.

The primary objective is to compare effectiveness of standard of care (SOC) (i.e., use of the family referral services (FRS)) with SOC plus VAPN in reaching contacts of index clients with HIV testing services. The percentage of contacts who receive HIV testing services within 1, 2, and 3 months of the initial offer of services to the index client will be compared between the SOC phase and the intervention phase (SOC plus VAPN).

Secondary objectives include:

1. To evaluate feasibility of implementing VAPN in real-world programmatic settings in high burden facilities in 6 priority districts in Malawi. Two key quantitative measures of feasibility will be used as follows:

• What is the cumulative percentage of eligible index clients offered VAPN services by study end?
• To what extent were the interventions implemented with fidelity? For example, a key measure of the fidelity of the Client Referral VAPN option is to assess what percentage of contacts, who did not return for their scheduled first appointment at the clinic, were subsequently traced according to the specified algorithm (i.e., up to 5 phone calls, and up to 2 home visits)?

2. To monitor trends in HIV diagnostic yield from SOC plus VAPN over time.

The study will include three options in additional to the FRS as part of the World Health organisation-recommended index testing approach. The first option is contract referral, in which the index client can choose to enter into a "contract" with the healthcare provider whereby he or she agrees to disclose their HIV status to all partners and refer them to HIV testing services (HTS) within a certain time frame. If the partners do not access HTS within this period, the providers will contact the partners directly to notify them that they may have been exposed to HIV; the providers will then offer voluntary HTS while maintaining the confidentiality of the index client. The second option is that of provider referral, in which the index client can choose to have the healthcare provider contact the client's partners directly, provide them with an appropriate health message, and offer them voluntary HTS, while maintaining the confidentiality of the index client. The third option is dual referral, in which the index client can choose that a trained provider sits with the client and his/her partner at a suitable time and location (usually a private room at the health facility) to provide support as they potentially test together or the index client discloses his/her HIV status with the provider offering voluntary HTS to the partner.

Conditions

HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Assisted Partner notification services

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.

Group Type: OTHER

Assisted Partner Notification Services

Intervention Type: OTHER

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

Interventions

Assisted Partner Notification Services

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.
• Index clients who are inpatients and pregnant women are eligible for inclusion in the study and in 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.

Exclusion Criteria

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:

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Agency for International Development (USAID)

FED

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Elizabeth Glaser Pediatric AIDS Foundation

OTHER

Sponsor Role: collaborator

Ministry of Health, Malawi

OTHER_GOV

Sponsor Role: collaborator

Lighthouse Trust

OTHER

Sponsor Role: lead

Responsible Party

Hannock Tweya, PhD, MSc

Director of Monitoring, Evaluation and Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ministry of Health Facilities

Lilongwe, , Malawi

Site Status: RECRUITING

Countries

Malawi

Central Contacts

Hannock Tweya, PhD

Role: CONTACT

h_tweya@lighthouse.org.mw

+265 1758940 ext. 220

Odala Sande, BSc

Role: CONTACT

o_sande@lighthouse.org.mw

+265 1758940 ext. 225

Facility Contacts

Thom Chaweza, MPH

Role: primary

t_chaweza@lighthouse.org.mw

+265 758 940 ext. 236

Jane Chiwoko, BSc

Role: backup

j_chiwoko@lighthouse.org.mw

+265 758 940 ext. 236

Other Identifiers

VAPN

Identifier Type: -

Identifier Source: org_study_id