CBCHB PARTNER NOTIFICATION STUDY
STANDARD OPERATING PROCEDURES: 21 February 2011 - Page 6
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The Cameroon Baptist Convention
Health Board (CBCHB)
Extended Forum of Care (EFC) Program
PARTNER NOTIFICATION (PN) IN CAMEROON:
AN INNOVATIVE APPROACH TO HIV PREVENTION
STANDARD
OPERATING
PROCEDURES
CBCHB PARTNER NOTIFICATION STUDY
STANDARD OPERATING PROCEDURES: 21 February 2011 - Page 6
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TABLE OF CONTENTS
Common Acronyms 3
Partner Notification Study Overview 4
Background 4
Specific Aims 5
Methodology 5
Overview 5
Study Location and Recruitment of Participants 6
Inclusion/Exclusion Criteria 6
Procedures for Partner Notification and Enrollment into the Study 6
Procedure to draw blood from index cases and partners and perform HIV testing 8
Research Team and Project Roles 9
Study Timeline 10
Data Management Procedures 11
Data Collection Forms 11
Data Entry, Storage, and Analysis Plan 12
Good Clinical Practice/Research 12
Ethical Research 12
Study Benefits 13
Study Risks 13
Writing Procedures 13
Persons using the SOP 14
Maintaining Confidentiality 14
Appendix A: Consent Form 15
Appendix B: Study Data Instruments 17
Appendix B1: Index Person Interview Form – Step 1 17
Appendix B2: Index Person - Partner Form – Step 2 20
Appendix B3: Partner Notification Follow-Up Form- Step 3 24
Appendix B4: Eligibility Form –Step 4 29
Appendix B5: Baseline Survey –Step 5 30
Appendix B6: Three-Month Follow-Up Survey-Step 6 32
Appendix C: Health Advisors’ Weekly Abusive Cases Report Form 37
APPENDIX D: Guidelines for conducting Partner Notification for HIV 39
CBCHB PARTNER NOTIFICATION STUDY
STANDARD OPERATING PROCEDURES: 21 February 2011 - Page 6
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Common Acronyms
AIDS Acquired Immune Deficiency Syndrome
ARV Antiretroviral
ART Antiretroviral Therapy
CBCHB Cameroon Baptist Convention Health Board
EFC Extended Forum of care
CFAR Center for AIDS Research
C&T Care and Treatment
HIV Human Immune Deficiency Virus
IRB Institutional Review Board (Research Ethics Committee)
NWR North West Region
PI Principal Investigator
PMTCT Prevention of Mother To Child Transmission of HIV
PN Partner Notification
SOP Standard Operating Procedures
SWR South West Region
UNC University of North Carolina
UW University of Washington
ZDV/AZT Zidovudine
CBCHB PARTNER NOTIFICATION STUDY
STANDARD OPERATING PROCEDURES: 21 February 2011 - Page 6
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Partner Notification Study Overview
Purpose: The purpose of this study is to determine social harms and behavior changes associated with provision of PN services in Cameroon, West Africa.
Participants: Two hundred persons newly diagnosed with HIV infection (index cases) and their partners
Procedures: After consecutive index cases and their partners receive PN services, we will recruit them to participate in this study and will enroll them, if they sign our consent form.
Background
Partner notification (PN) is widely used in Europe and North America to reduce the spread of infectious diseases. However, it has rarely been used in Africa to reduce HIV transmission. In 2006, the University of North Carolina Fogarty Program supported training for Prof. Tih Pius Muffih, the Director of Health Services of the Cameroon Baptist Convention Health Board (CBCHB), on contact tracing and partner notification, which was given by the North Carolina Health Department. Subsequently, in 2007, Prof Tih used training tools that he acquired to begin a pilot PN program targeting newly diagnosed HIV-infected person, including youth, in the North West Region (NWR) of Cameroon because of the high adult HIV seroprevalence (8.7%). The program was called “Extended Forum for Care” to emphasize its importance in identifying persons living with HIV and referring them to care and treatment. CBCHB has trained 48 health advisors who are doing PN in North West Region (NWR) and South West Region (SWR) of Cameroon. The health advisors interview index HIV cases about their sexual partners, inform the partners they are at risk for HIV infection without revealing the identity of the index case, pre-test counsel the partners, offer them rapid HIV testing in a medical facility or in their home, educate index cases and partners on HIV prevention and risk reduction, and refer those partners who test positive for care and to HIV support groups (See Appendix D on the guidelines and procedures used). The health advisors include HIV educators, laboratory technicians, clinical nurses and pastors. Some of the health advisors have been recruited from support groups of persons living with HIV. From August 2007 through December 2010, staff provided PN services to 6,642 persons with HIV infection. These persons identified 7,200 sex partners, of whom 5,271 partners (73.2%) were notified and 3,977 (75.5%) of those notified partners were counseled and tested. Of the 3,977 tested partners, 2,154 (54.2%) were HIV positive and 1,310 (60.8%) of the HIV positive partners were linked to HIV care and treatment. Only two cases of domestic abuse associated with PN have been reported. CBCHB has integrated PN services into its comprehensive AIDS Care and Prevention Program.
The CBCHB is a non-profit; faith based health care organization that includes five hospitals, two of them with over 250-beds, 24 integrated health centers, 43 primary health centers, a pharmaceutical production and distribution center, a training school for health personnel, and other critical health services for a population base of six million people in six of Cameroon's ten regions (see http://www.cbchealthservices.org/). The CBCHB has collaborated with many governmental and non-governmental health care and funding organizations, including USAID, UNICEF, Columbia University, CARE, the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), and the Ministry of Health (MOH) and regional health departments in Cameroon. CBCHB has partnered with the University of North Carolina (UNC) and the University of Washington (UW) to implement PN in Cameroon, which builds on the experience UNC and the NC Department of Health have had in implementing PN in North Carolina and the UW has had in implementing and studying PN in Washington. UNC and UW have provided technical support, especially in designing the essential tools for the program. They will also assist us in analyzing the data and preparing scientific reports for publication.
The CBCHB program is among the first HIV PN programs instituted in Africa. CBCHB has used its extensive network of health facilities in the NWR and SWR and expects to expand PN services to reach 115 sites where they support PMTCT activities, as well as continue to provide PN services as part of youth and community testing activities. In parallel work, investigators at the UNC have explored the best approach to PN in a pilot study in Malawi: 240 index patients named 302 sexual partners and 107 returned for counselling. Eighty five per cent of partners were HIV positive and the median CD4 count among the partners was 344; 28% required treatment with ART[1]
In February 2010, Drs. Myron Cohen and Ada Adimora from UNC and Dr. Matt Golden from UW met with Prof. Tih and Drs. Thomas Edith Welty from CBCHB and encouraged CBCHB to apply for funding from the UNC and UW Centers for AIDS Research (CFAR) to conduct a study of PN in Cameroon. CBCHB submitted a proposal, which was approved for $10,000 of funding from the UNC and $10,000 from UW CFARs ($20,000 total), pending IRB and HHS approvals.
Specific Aims
Aim 1: To assess the impact of PN services on partnership stability and social harms. We hypothesize that partnership dissolution and new episodes of social harm will be uncommon (<5%) among index cases and their partners and will not increase significantly above baseline rates.
Aim 2: To evaluate the program’s ability to link index cases and HIV positive partners to care. We hypothesize that 90% index cases and 70% of their partners who test HIV positive will be successfully linked to appropriate medical care.
Aim 3: To evaluate changes in risky sexual behaviors after receipt of PN services. We hypothesize that compared to the three months prior to receiving PN services, the mean number of sexual partners will decrease significantly and the use of condoms will increase significantly in the three months after receiving PN services for index cases and for their HIV positive and negative partners.
Methodology
Overview
We will collect survey and program data on all index cases and their partners. Our co-investigators at UNC and UW have assisted us in designing the consent form (Appendix A) and data collection instruments (Appendices B1 to B6), which we piloted in August 2010. They will also assist us in analyzing the data collected and publishing scientific reports. We will administer baseline and three-month follow up surveys on 200 consecutive index cases and their HIV positive and negative partners who consent to participate and document the HIV care and treatment they receive and their CD4 results. We will continue to refer all index cases and their HIV positive partners to care and treatment. When possible, we will confirm results at treatment centers. Index cases will include HIV positive men and women who are diagnosed through a health care facility or community screening. All study staff will monitor social harms and will follow up such cases to reduce the risks of physical, mental and economic harms (Appendix C). The staff will sign confidentiality pledges (Appendix D) and will be trained in interview techniques that will increase the likelihood of truthful responses. This information will be critical in understanding whether PN is associated with social harms and whether index cases and their HIV positive contacts can be successfully enrolled into HIV care and treatment programs. Our experience in linking HIV positive mothers into care and treatment will guide us in the establishment of systems to refer index cases and their HIV positive partners into care and treatment.
Study Location and Recruitment of Participants
The study will be conducted at the following CBCHB facilities:
Baptist Hospital Mutengene, SWR, Cameroon
Banso Baptist Hospital, Kumbo, NWR, Cameroon
Nkwen Baptist Health Center, Bamenda, NWR, Cameroon
In each participating facility, study participants will be recruited from consecutive index cases who have been newly diagnosed with HIV. Recruitment will continue until 200 index cases consent to participate. All their partners will be recruited after receiving PN services and will be enrolled, if they sign our consent form.
Inclusion/Exclusion Criteria
To be eligible for participation in the study, individuals must meet the following inclusion criteria:
Index Person Eligibility:
· Newly diagnosed HIV positive men and women aged 18 or over who have received PN services and have signed a consent form.
· Newly diagnosed HIV positive married men and women under age 18 who have who have received PN services and have signed a consent form. Marriage is an emancipating condition in Cameroon, so parental consent is not required.
Partner Eligibility:
· Men and women, of any HIV status, aged 18 or over who have who have received PN services and have signed a consent form.
· Married men and women, of any HIV status, under age 18 who have received PN services and have signed a consent form. Marriage is an emancipating condition in Cameroon, so parental consent is not required.
Procedures for Partner Notification and Enrollment into the Study
1. Person comes to selected antenatal care clinic or voluntary counseling & testing facility for HIV testing.
2. Person is newly diagnosed HIV positive.
3. Newly diagnosed HIV positive individual is offered PN services.
a. If accepted – continue to 4
b. If refused – refer to HIV medical care and treatment and collect demographic information if possible.
4. Newly diagnosed HIV positive individual (Index person) is interviewed to collect demographic and sexual behavior information – Index Person Interview Form (B1)
5. Ask if the index person has ever previously had an HIV test and for the results of the test(s).
a. If they have only had HIV negative test(s), then ask them for the date of the most recent HIV negative test and for their sexual partners since that date.
b. If they have NEVER had an HIV test or if have only tested HIV positive during previous tests, then we ask them for their sexual contacts over the past two years OR their last two sexual partners, whichever is more
6. Index person is interviewed to collect information on their reported sexual partners – Index Person Partner Form (B2)
7. Index person is asked whether they would like to be part of the study:
a. If they accept – continue to 8
b. If they refuse – continue to 10
8. Administer Study Eligibility Form (B4) and Study Informed Consent
9. Administer Study Baseline Survey Form to the Index case and schedule date for 3-month follow-up visit
10. Health Advisor attempts to contact partners reported by index person.- Partner Notification Follow-Up Form
11. All contacted partners are administered the Partner Notification Follow-Up Form (B3).
12. All contacted partners receive HIV testing, if they verbally consent.
a. If partner is HIV-positive:
i. Ask if the HIV-positive partner would like to receive PN services
1. If they accept PN services - administer Index Person Interview Form, Index Person Partner Form (B3). Then continue to 12(a)ii.
2. If they refuse PN services – continue to 12(a) ii.
ii. Ask if the HIV-positive partner would like to be part of the study
1. If they accept to be part of the study:
a. Administer Study Eligibility Form and Study Informed Consent
b. Administer Study Baseline Survey Form (B5) and schedule date for 3-month follow-up visit
2. If they refuse to be part of the study - STOP.
b. If partner is HIV negative, ask if the HIV-negative partner would like to be part of the study
1. If they accept to be part of the study:
a. Administer Study Eligibility Form and Study Informed Consent
b. Administer Study Baseline Survey Form (B5) and schedule date for 3-month follow-up visit
2. If they refuse to be part of the study - STOP.
Procedure to draw blood from index cases and partners and perform HIV testing
As the transmission of HIV and other blood-borne pathogens can occur through contact with contaminated needles, blood, and blood products, appropriate blood and secretion precautions will be employed by all personnel in the drawing of blood and handling of all specimens for this study, as currently recommended by the US Centers for Disease Control and Prevention and the National Institutes of Health.”