Assessing the Effectiveness and Feasibility of Voluntary Assisted Partner Notification Services (VAPN)

Assessing the Effectiveness and Feasibility of Voluntary Assisted Partner Notification Services in High HIV Burden Districts of Malawi: a Pragmatic, Non-Randomized Stepped-Wedge Study

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

Study Overview

• Status: Unknown
• Conditions: HIV Infections
• Intervention / Treatment: Other: Assisted Partner Notification Services

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1785
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannock Tweya, PhD; Phone Number: 220 +265 1758940; Email: h_tweya@lighthouse.org.mw
• Study Contact Backup: Name: Odala Sande, BSc; Phone Number: 225 +265 1758940; Email: o_sande@lighthouse.org.mw

Study Locations

• Malawi
  • Lilongwe, Malawi
    • Recruiting
    • Ministry of Health facilities
    • Contact: Thom Chaweza, MPH; Phone Number: 236 +265 758 940; Email: t_chaweza@lighthouse.org.mw
    • Contact: Jane Chiwoko, BSc; Phone Number: 236 +265 758 940; Email: j_chiwoko@lighthouse.org.mw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• There are no exclusion criteria for contacts to be included in the study or receive HIV testing services if they or their guardian desire services. Contacts who are <13 years old will not be contacted by phone under any VAPN contact outreach scenario.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

Other: Assisted Partner Notification Services; Three options for partner Notification services; contract referral, provider referral and dual referral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of contacts who returned for HIV testing	Number of contacts who return for HIV testing divided by the number of contacts who are expected to return for HIV testing	10 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV Yield over time	Proportion of Contacts who tested HIV positive during the study period	10 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2018
• Primary Completion (Anticipated): April 29, 2020
• Study Completion (Anticipated): April 29, 2020

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Active HIV Case finding; Partner Notification Services
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: VAPN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No