PEPFAR Guidance on Implementing Safe and Ethical Index Testing Services

WHAT IS THE PROBLEM?

PEPFAR recognizes the importance of providing all HIV Testing Services (HTS) in accordance with internationally recognized standards to ensure the provision of safe and ethical HTS to all clients. PEPFAR minimum standards for safe and ethical Index/Partner Notification HTS include adherence to the 5Cs (Consent, Confidentiality, Counseling, Correct, and Connection/linkage), inclusion of Intimate Partner Violence risk assessment, monitoring adverse events, and training and supervising providers on the rights of clients, informed consent, and ethics. PEPFAR is committed to ensuring that (1) all PEPFAR-supported sites meet the minimum standards for safe and ethical index testing services AND (2) routine monitoring and remediation practices are in place for accountability and action.  PEPFAR believes that working collaboratively with diverse stakeholders is essential to improve the quality and effectiveness of services we support. As such, PEPFAR will work collaboratively with civil society partners, government leaders, and PEPFAR Implementing partners to ensure all voices are heard, remediation actions are taken in a timely manner, and the safety and ethical treatment of clients remains of utmost importance.

WHAT IS THE TOOL?

Here we provide PEPFAR’s Guidance on Implementing Safe and Ethical Index Testing services. These materials include a summary slide deck (PDF), several tools and implementation forms that address each of the following components listed below. Collectively, these materials will help ensure minimum standards for safe and ethical index testing are continuously met, and relevant remediation and accountability measures are in place.

Please note that the materials posted below are for informational purposes only. Index testing site assessments may be done by an individual or team that includes the United States Government (USG) staff, PEPFAR Implementing Partner, Ministries of Health (MOH), and/or civil society partners. USG staff are responsible for oversight and working with Implementing Partners to implement remediation, if necessary.

All PEPFAR-supported programs should take steps to implement safe and ethical index testing services by:

1. Monitoring site and provider-level compliance with minimum standards for index testing.
2. Obtaining informed consent prior to the elicitation interview and before contacting partners.
3. Conducting an Intimate Partner Violence risk assessment for each named partner and providing appropriate services for clients experiencing violence.
4. Implementing a robust mechanism for detecting, monitoring, reporting, and following up on any adverse events associated with index testing services.
5. Utilizing quality assurance and accountability to remediate any gaps in the provision of index testing services.

RESOURCES FOR IMPLEMENTING SAFE AND ETHICAL INDEX TESTING

These resources include a Guidance document (slide deck in PDF form) with background information and details on each of the five components listed above. All implementation forms and tools referenced in the slide deck are also provided below, along with a short description.

• Guidance for Implementing Safe and Ethical Index Testing (PDF) [2 MB]

1. Compliance with Minimum Standards: These site assessments tools will allow USG teams to work with implementing partners, local stakeholders, and governments to assess whether PEPFAR-supported sites providing index testing services meet the minimum standards for safe and ethical index testing. These minimum standards (described in the Guidance mentioned above) align with the core 5Cs of HIV Testing Services: Consent, Confidentiality, Counseling, Correct Test Results, and Connection to Treatment or Prevention Services. The REDCap tool is designed to be completed through an online platform, but we’ve also included PDF and excel versions with the same content as the online version.
   • CDC (REDCap) [92 KB]
     • This tool can be used to assess whether sites meet minimum standards for safe and ethical Index Testing (online or paper-based version) and should be filled out for every facility and community-based IP providing index testing.
   • USAID (REDCap) [85 KB]
     • This tool can be used to assess whether sites meet minimum standards for safe and ethical Index Testing (online or paper-based version) and should be filled out for every facility and community-based IP providing index testing.
   • Excel version of the REDCap [124 KB]
     • This version can be used, if needed, instead of the online REDCap tool. It includes all the same content as the online REDCap.
2. Obtain Informed Consent
   • Script for Obtaining Consent for Index Testing Services [113 KB]
     • This script may be used by a counselor or health care worker to obtain informed consent from the index client prior to eliciting the names and contact information of sexual and needle sharing partner(s) and biological children.
3. Intimate Partner Violence (IPV) Risk Assessment and Service Provision
   • Intimate Partner Violence (IPV) Assessment Questions for Use During the Partner Elicitation Interview [83 KB]
     • These screening questions should be used during the partner elicitation interview.
   • Caring for Women Subjected to Violence: A LIVES (Listen, Inquire, Validate, Enhance safety and support) approach, curriculum for training health-care providers.
     • Evaluation Tools [801 KB]
     • Exercise Resources [3 MB]
     • Facilitator Guide [5 MB]
     • Participant Handouts [3 MB]
4. Adverse Events Monitoring and Reporting
   • Index Testing Adverse Event Investigation Form [84 KB]
     • This form may be used to document reports related to adverse events.
   • Adverse Event Report Form for Index Testing Services [113 KB]
     • This form can be utilized by healthcare workers to document any reports of adverse events reported by clients during or following their participation in index testing services.
   • Customer Complaint Form for HIV Services [88 KB]
     • Complaint Form for customers to fill out anonymously and/or confidentially regarding the HIV services they received at a facility or community site.
   • Patient Rights Poster [117 KB]
   • Index Testing Register Excel Spreadsheet [122 KB]
     • This sample index testing register was developed to serve as an example of how one can record provision of index testing services in a register.
5. Quality Assurance and Accountability
   • SIMS Standards for Monitoring Ethical and Safe Services [178 KB]
     • List and description of existing Site Improvement Monitoring System (SIMS) Core Essential Elements (CEEs) (version SIMS 4.0) related to Safe and Ethical Index Testing Services. Also includes CEEs to be added in SIMS 4.1 (beginning October 2021). These CEEs all align with PEPFAR minimum standards for safe and ethical index testing.
   • Supportive Supervision Tools: Interview and Field Visit Observation Forms [126 KB]
     • Observation forms used to evaluate how Index Testing Providers performed in a variety of skills and areas related to patient experience, and how the provider can improve.
   • Gender Based Violence (GBV) Quality Assurance Tool (QA) [5 MB]
     • This quality assurance tool offers health care providers, facilities, and program planners a platform to start, strengthen, or expand post-GBV health services through monitoring adherence to 28 evidence-based quality standards.
6. Sample Data Sharing Agreement Template
   • This template provides an example for a memorandum of understanding between two organizations (or health facilities) who would like to engage in a shared confidentiality relationship in order to facilitate index testing, linkage to treatment, tracing of individuals with a missed appointment, and other HIV services. Organizations should feel free to adapt and customize this agreement as appropriate.