Assessing the Effectiveness and Feasibility of Voluntary Assisted Partner Notification Services (VAPN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03944395|
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Other: Assisted Partner Notification Services||Not Applicable|
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:
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)?
- 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 (Clinical Trial)|
|Estimated Enrollment :||1785 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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|
|Actual Study Start Date :||May 21, 2018|
|Estimated Primary Completion Date :||April 29, 2020|
|Estimated Study Completion Date :||April 29, 2020|
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
- Proportion of eligible index clients offered VAPN services [ Time Frame: 10 months ]Number of eligible index clients who are offered VAPN divide by the number of all eligible index clients identified for enrolment
- Proportion of contacts who returned for HIV testing [ Time Frame: 10 months ]Number of contacts who return for HIV testing divided by the number of contacts who are expected to return for HIV testing
- HIV Yield over time [ Time Frame: 10 months ]Proportion of Contacts who tested HIV positive during the study period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944395
|Contact: Hannock Tweya, PhD||+265 1758940 ext email@example.com|
|Contact: Odala Sande, BSc||+265 1758940 ext firstname.lastname@example.org|
|Ministry of Health Facilities||Recruiting|
|Contact: Thom Chaweza, MPH +265 758 940 ext 236 email@example.com|
|Contact: Jane Chiwoko, BSc +265 758 940 ext 236 firstname.lastname@example.org|