PDF OMMUNITY ASED HIV SELF-SREENING (Assisted and Un-Assisted) - Spiritia

Term of Reference

COMMUNITY BASED HIV SELF-SCREENING (Assisted and Un-Assisted)

SPIRITIA FOUNDATION

BACKGROUND

In Indonesia, adult HIV prevalence remains high, with pronounced social and economic inequity in access to HIV prevention, testing and care services. Prevalence is even higher among key populations, specifically Men who have Sex with Men (MSM), due to their high risk of HIV infection and low uptake of HIV testing. Stigma among these groups act as an additional barrier to accessing facility-based HIV-related services.

Recent HIV epidemic modeling (MoH, 2016)¹ indicates that although generally the new infection trend is flat, but the new infections among MSM people are still growing up until 2030.

Figure 1 below depicts that by year 2030, Indonesia is not heading to ending the epidemic.

Figure 1: Estimated and Projected Annual Number of New HIV Infections, 1990-2030*

One of the main obstacles to improving treatment coverage is an insufficient volume and decentralization of HIV testing. Although the number of HIV tests performed and the number of HIV-positive persons identified continues to increase (see table 1), these numbers fall far short of that needed to reach more aggressive treatment aspirations. Beyond numbers being tested, the available data indicate that positivity rates of HIV testing have been declining (but not for all groups between 2015 and 2016) and tend to be lower than HIV prevalence for KAPs measured in the 2015 IBBS. This may indicate that the highest risk KAPs are not being tested.

Barriers to HTC and ART initiation include long distance and congestion of health facilities, concerns about lack of confidentiality and privacy, and high out-of-pocket costs (MacPherson, et al., 2012; Morin, et al., 2006; Angotti, et al., 2009). These barriers are particularly significant among certain demographics, including men, young people, impoverished rural residents (Weinreb &

Stecklov, 2009) and key populations (i.e., MSM) (Govindasamy, Ford, & Kranzer, 2012). Therefore, current HTC strategies, which are predicated on clinic-based service delivery, need to be complemented by affordable community-based services that allow better coverage, particularly for key populations and rural populations in Indonesia.

1 Estimates and Projection of HIV/AIS 2015-2030, MoH, 2016

*Source: Estimates & Projection of HIV/AIDS 2015-2030, MoH 2016

Table 1: Positivity Rates in HIV Testing, 2011-2016 (MoH program data)

Indonesia lags behind other countries in the region in terms of ART coverage. While some success has been achieved in increasing the number of persons on ART reaching nearly 78,000 by the end of 2016, the most recent “cascade” data available indicate that further progress is needed.

According to UNAIDS data, there were an estimated 620,000 people living with HIV in 2016, among whom 13% were accessing antiretroviral therapy.

Several modes of HIV testing will be supported in order minimize physical and psycho-social barriers to HIV testing. These include (1) testing (rapid test) at health facilities, (2) use of mobile clinics, (3) linkage with “community clinics” (i.e., private clinics) providing “friendly” services for KAPs (e.g., to date MSM, TG and PWID), and (4) and assisted and unassisted HIV self-screening (saliva-based) models in Acceleration districts. In both cases, persons testing positive will be referred for formal diagnostic testing. In order further expand access to HIV testing, the number of Puskesmas offering HIV testing services will be further increased in Medium and Comprehensive districts.

In 2015, the WHO issued the Consolidated HIV Testing Guideline and recommended a new approach to increasing the scope of HIV testing toward the 90-90-90 global target. The new recommendations are HIV testing conducted by trained non-health providers and using rapid diagnostic tests (RDTs) and HIV testing in the context of surveillance. HIV testing conducted by trained non-health (lay provider / lay-testers) and using rapid diagnostic tests (RDTs) is

KAP Metric 2011 2012 2013 2014 2015 2016

Prev. Rate 2015 IBBS MSM No. Tests 4,315 8,088 14,460 21,519 24,881 70,297

No. HIV+ 537 1,263 2,207 3,318 4,216 8,335

Pos. Rate 12% 16% 15% 15% 17% 12% 26%

Waria No. Tests 3,664 4,180 7,303 6,696 5,495 13,669 No. HIV+ 433 415 1,083 632 437 951

Pos. Rate 12% 10% 15% 9% 8% 7% 17%

FSW No. Tests 49,922 50,099 73,369 73,023 69,218 88,817 No. HIV+ 2,350 2,316 3,489 2,581 2,336 2,506

Pos. Rate 5% 5% 5% 4% 3% 3% 5%

PWID No. Tests 10,490 9,808 12,500 11,574 6,295 13,664 No. HIV+ 2,962 2,377 2,671 1,844 860 921

Pos. Rate 28% 24% 21% 16% 14% 7% 2%

Prison No. Tests 17,201 23,593 22,860 N/A 18,933 27,590 No. HIV+ 309 432 320 N/A 211 716

Pos. Rate 2% 2% 1% 1% 3% 2%

recommended to improve the scope of HIV testing with the first 90 target. The trained non-health personnel referred to are ordinary people / communities trained and assisted by health workers (laboratories), so they can safely and effectively test HIV with RDT. This recommendation complements some of the previous recommendations on improving the scope of HIV testing, namely the expansion of HIV testing of healthcare initiation (PITC) in all health-care facilities and community-based screening, including those in Indonesia in the form of mobile HIV KT services.

The study developed and tested the implementation of HIV Self Screening (HIVSS) services using oral fluid, hereinafter referred to as community-based HIVSS. This model has a uniqueness that is:

• HIV screening is performed by the Outreach Worker, not the health worker

• HIV screening is conducted at flexible times and places

• HIV examination without needle syringe and without taking blood

In addition, this study also assessed the feasibility of community-based HIVSS model services.

Self-Screeninig for HIV is becoming an increasingly plausible option with the recent development of simple and accurate oral test kits, which have proven to be highly accurate when used by lay clients. However, HIV Self Screening Study to date has largely been limited to a single delivery model among general populations. More Study is needed on the acceptability of HIV Self Screening among key populations and the social benefits and harms of introducing HIV Self Screening to particularly vulnerable groups, such as MSM, TG and PWID.

HIV self-sceening (HIVSS) can overcome these barriers by providing a quick, convenient, and confidential option, and has the potential to accelerate new HIV case detection in Indonesia.

Study Finding and Dissemination

Early evidence in previous study points to substantial willingness to and the potential of HIV Self Screening products to provide affordable community-based HTC and improve linkages to HIV services. The results of this Study will be used to guide the introduction of self-screening into community-based HTC models and the formation of national and international policies around HIV Self Screening. Results will be disseminated to the Ministry of Health (MoH) HIV Unit and related Stakeholders. Findings will also be distributed internationally to global health policy makers, nationally to the Indonesian government, and regionally to District and Council Health Offices.

Study Objectives

Study Objectives- Main

 To explore the model of community-based HIV Self Screening using the oral fluid test as an integral part of the existing HIV counseling and test among MSM, TG and PWID community who are

refusing clinical test at health facilities.

Study Objectives- Specific

 To assess the extent to which community HIV self-screening increases numbers of MSM, PWID and TG testing for HIV at health facilities

 To assess the extent to which increased testing at health facilities translates into increased numbers of MSM, PWID and TG initiating treatment

 To assess the relative merits of alternative modes of community self-screening (i.e., assisted vs.

unassisted) for increasing the (1) acceptability and feasibility of community self-screening and (2) the rate of follow-on confirmatory testing at health facilities

 To assess the sensitivity and specificity of community Self-Screening in relation to formal testing at health facilities

CONSEPTUAL FRAMEWORK

METHODOLOGY Study Location

The Study will take place in 10 districts in 8 provinces (DKI Jakarta, West Java, East Java, Central Java, Yogyakarta, Bali, North Sumatera, South Sulawesi). The districts are part of acceleration districts where complete package interventions (HIV testing at all Puskesmas and district hospitals, HIV treatment at all Puskesmas and district hospitals, including pediatric treatment, “Test and start” phased in over three years, Viral load test access including cost for VL test, EID access for infants from positive mother, Use of ART stock out Early Warning Indicator (EWI), ADR and PDR monitoring (drug resistance), Enhanced KAP outreach (targeted districts), District HIV and STI mentor team, Community-based clinics in some districts) and outreach for all KAPs (FSW, MSM, TG, PWID) exists. The complete package interventions will support the HIVSS implementation and the districts also represent the three Indonesian time zone.

Study Period

The study will be conducted in April 2019 to September 2020 or 18 months. The preparatory phase will be in April - June 2019, fieldwork will be conducted from July 2019 to June 2020 and reporting will be conducted in July - Sept 2020.

Study Design

The design of this study is a prospective cohort, in which the investigator follows a group of subjects (LSL, TG and PWID) and observes the behavioral changes that occur, i.e. willingness to follow the test (testing) and access to health services. Studiers will observe the length of change from the first contact to providing access to health care and / or are willing to take an HIV test. One person will be followed for one year and will take 2 test if the results are positive (HIVSS and Confirmatory Test), but if the results are negative it is very possible to take the test more than 2 times (HIVSS, Confirmatory Test, Repeated Confirmatory Test after 3 months. Client will be re-visit if at one time the target of MSM, TG and PWID that has been reached does not also access health service. There will be only one data collection points at first contact.

Sample size

The sample size will take at least 4.038 out of the total target in 2019. The number of samples is a new client who has never had a previous HIV test or tested more than 12 months ago.

Determination of sample size considers the desired value of α, the proportion of previous relevant research, the limit value of absolute error or precision, and the design value of the effect as in the Lemeshow formula below

n = Sample Size

Z = Z score based on the desired α value (for 95%, Z = 1.96) P = the expected population proportion (set = 0.5)

d = the level of precision desired (assumed to +/- 5 percentage points)

deff = design effect to compensate for clustering at the district level (1.5 assumed)

An additional 20% was added to the calculated minimum sample size of 3.365, to allow for drop outs and rejected subjects due to exclusion criteria. Therefore, the sample size needed for this study is 4,038

Study Sample

The population of this study consists of the following groups:

1. MSM - Male older adolescents or adults who engage in sexual activities with members of the same sex (regardless of their identified gender).

2. TRANSGENDER – Transgender is an umbrella term to describe people whose gender identity and expression does not conform to the norms and expectations traditionally associated with their sex at birth. (see UNAIDS Terminology Guidelines, 2015)

3. PWID – People who inject drugs The inclusion criteria:

1. MSM, Transsexual (TG) and People Who Inject Drugs (PWID) 2. Never had HCT or not having HCT in the past 12 months, 3. 17 years old or older,

4. Willing to take the Oral Fluid Screening.

Data collection

HIV Self Screening Distribution

Spiritia Foundation will pilot one models of the HIVSS distribution approach which is the HIVSS kit distribution model through outreach workers (community-based)

HIVSS kit distribution model through outreach workers (community-based)

Outreach workers will be provided with training in HIV Self Screening, instructional leaflets and Information, Education and Communication (IEC) materials in Bahasa, used kits to show

participants how to interpret positive, negative and inconclusive results, a cotton bud and vial of water to demonstrate the mouth swabbing and development process, and a buffer stock of HIV screening kits to be stored in a locked container in their own office/home. There are no sharp or hazardous materials.

All participants will be offered pre- and post-test information and counselling, including how to access confirmatory testing and ART services. Participants will also be given the opportunity to discuss any fears about the process or results prior to testing and to disclose their status and receive advice and support for post-test services. A toll-free telephone number will also be provided with the HIVSS kit, which can be used to access verbal pre-test information, test instructions, and results- based post-test information and also to report any adverse events arising as a consequence of HIVSS.

Process data on HIVSS delivery by outreach worker will be captured using HIVSS logbooks (e.g., date, name, number of test-kits taken) but not results. If considered acceptable when discussed in the FGDs and participatory workshops, participants will be encouraged to return used kits with a self-completed questionnaire (SCQ) in an opaque envelope. The envelope will be posted in a locked opaque “ballot box” provided by the study team to each peer distributor.

Kits will be replaced by Studier following inspection of an HIVSS logbook. HIVSS logbooks will be kept at the outreach worker’s office/home in a locked container.

Linkage to care following HIV Self Screening

Participants will not be required to disclose their HIVSS results to the outreach worker. Outreach worker will receive training in providing post-test support, including providing ‘generic’ information as well as standard, results-based support. Outreach worker will be trained on the importance of maintaining confidentiality.

Confirmatory testing and linkage to care for pilot study participants who self-test HIV positive will be supported through two approaches:

1. Information will be compiled on all clinics providing special services for MSM, TG and PWID within selected districts and will be provided by outreach worker along with a ‘self-referral card’ at the time of kit distribution.

2. The self-referral card will also provide details on how to directly access the study clinical officer or nurse who will offer confirmatory testing and counselling and provide the first 2 weeks of HIV care medications and registration into routine ART clinic services for subsequent management.

The key to the success of this Study is to make the first contact and save the contact data with an adequate database system. To make the first contact, we develop an outreach strategy in 4 ways, i.e. 2 new innovative ways (non-NGO and social media-based) and 2 ways with existing systems (NGOs and Health Services). Each of these must be supported by a strong field team. The team will then strengthen their knowledge and skills through standardized training in all study locations. We will also cooperate with various related parties and will partner with the competent parties in this field, such as NGOs, hospitals, health centers, clinics, etc.

The results of outreach worker performance will be directly monitored because the data will be sent in real time by using a website-based application. Outreach worker will use mobile phones / tablets as a medium to enter data from the results of field activities. Data that has been input will be directly sent to the database server, and Studier can directly monitor the results. With the system then everything that happens in the field can be directly monitored at any time. The Study team can directly provide feedback to the manager or team in the field. We will also be able to directly monitor the contacted KAPs data and ensure that data is not duplicated, or lost contact, or unwilling to engage in this study. All processes that occur in the field can be recorded with the recording and reporting system that we will develop later. The system we developed is an innovation of this study, which can be replicated for the development of other programs / activities.

Table 2: Design for Assisted and Unassisted

Assisted Unassisted

KAPs:  MSM

 TG

 PWID

 MSM

 TG

 PWID Districts:

10 selected districts 1. Kota Yogyakarta 2. Kota Jakarta Pusat 3. Kota Jakarta Barat 4. Kota Jakarta Utara 5. Kota Medan 6. Kota Makassar 7. Kota Bandung 8. Kota Surabaya 9. Kota Semarang 10. Kota Denpasar

10 selected districts 1. Kota Yogyakarta 2. Kota Jakarta Pusat 3. Kota Jakarta Barat 4. Kota Jakarta Utara 5. Kota Medan 6. Kota Makassar 7. Kota Bandung 8. Kota Surabaya 9. Kota Semarang 10. Kota Denpasar

Data analysis

Data collection will be done using a prepared questionnaire that will record the characteristics of KAPs, target group eligibility and referrals to clinics and offering OFT. Study subjects who tested for HIV at a health facility received the standard outreach and support activities provided under the community-based intervention model being implemented by Yayasan Spiritia and partners subsequent to formal testing. All outreach contacts, services offered, services refused and accepted, results of community-based HIV tests and receipt of health facility-based HIV testing were recorded on standard Case Report Forms (CRFs). Data were entered into a computer data and stored for analysis at the conclusion of data collection. The data will be entered and stored in the database using the SPSS program. The primary method of analysis was tracing study subjects through the various steps/stages of the outreach, advocacy and testing processes. Data analysis will be carried out using SPSS program to calculate the distribution and frequency of the variables studied. The type of variables that we will use are demographics, acceptability of assisted and unassisted screening. Logistic regression will be used to analyze the data and to find the best fitting model to describe the relationship between the dichotomous characteristic of interest (dependent variable = response or outcome variable) and a set of independent variables.

Study Tools

The tools to be prepared are guidelines for the implementation of the activities, covering various SOPs, namely: HIV screening using fluid oral fluid examinations performed by the OW, development of a data base system, recording of processes and recording of testing results, referral systems, and monitoring and evaluation.

Study Etiquette

The study will be explained in the respondent's native language (Indonesian language).

The respondents will be informed that the participation in the study is voluntary and no action will be taken if they choose not to participate. They will be informed of the objective of the study and the test that are involved.

Those who agree to participate will be ensure that they will only be identified by a peculiar serial number known only to Studier and the information that they disclose and result of the test for HIV are confidential and they have to sign the informed consent. Before testing for HIV, all the

respondents will get counseling about HIV/AIDS and have to sign the informed consent. After testing for HIV, all respondents will be informed of their results and get counseling after test.

The proposal will be submitted to Ethical Review Committee (SDK) for approval.