Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-04 @ 8:57 AM
Study NCT ID:
NCT03944395
Status:
UNKNOWN
Last Update Posted:
2019-08-13
First Post:
2018-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Effectiveness and Feasibility of Voluntary Assisted Partner Notification Services
Sponsor:
Lighthouse Trust
Organization:
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VAPN
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: