Community Based Screening for HIV Self Testing in FSW in 23 Priority Districts in Indonesia

NCT04578145 | Unknown

• 1 other identifier: IDN09MHH
• Study Type: interventional
• Target: 1,522
• Locations: 1 country
• Sites: 1

Brief Summary

Indonesia is not yet on course to end HIV and AIDS by 2030. Epidemic transmission of HIV infection among key affected populations (KAPs), specifically FSWs, crucially has contributed to not achieving the target. Although the number of HIV tests performed annually has grown steadily in recent years, reaching 3,077,653 in calendar year 2018, pregnant women is accounted for a fairly large proportion of an increased number of persons being tested (MoH, 2018). Regarding the FSWs, it has been a significant challenge to increase HIV testing uptake among this population. The challenge has been affected by Indonesia's national policy to close brothels. As consequence, many FSWs have become hidden and hard to reach. The implementation national policy also impacts on the way of commercial sex transactions in which it becomes underground, especially many FSWs utilize the new popularity of digital platforms to sell sexual services. It needs more effective case finding strategies to be implemented to reach them accordingly. If it is considered from the FSWs side, there are some barriers to access HIV test services according to several reports. They consist of lack of money, time, stigma, discrimination, low-risk perception, fear, lack of accessibility, reluctance of health service providers to offer HIV testing and limited human resources. Oral fluid HIVST using is an alternative to traditional HIV testing services in the facility or other healthcare provider testing (UNAIDS, 2016). For this study, OraQuick is used as an alternative strategy for HIV testing among FSWs. The primary objectives of this study are to assess whether proportion of FSW, who know their HIV status, increases or not; whether introduction of Oral fluid test increases the number of HIV testing at health facilities or not; and whether "assisted" or "unassisted" community HIV screening have a result to an increasing proportion of HIV testing at health facilities or not. Furthermore, CBS study aims to assess whether "assisted" and "unassisted" community HIV screening results to an increasing number of HIV positive case finding or not; and whether community HIV screening increases proportion of initiation of antiretroviral therapy (ART) or not. The secondary objectives of this study, meanwhile, are to measure acceptability of community-based self-screening in participation and to measure satisfaction of FSWs, who has participated, towards the delivery of community-based self-screening. Regarding the inclusion criteria of this study, participant must be women 18 years old or older at enrollment; has a transactional sex (vaginal, oral and/or anal) at least once in the past month; does not uptake HIV test in the last 6 months; and acknowledges her HIV status 'negative' or 'unknown'. There are several exclusion criteria, which are FSW does not able to fulfill one of inclusion criteria that has been explained above; FSW does not has desire to participate due to several reasons; and she is currently participating in another HIV prevention study. Outcome variables of this study are to compare the characteristic FSWs who receive self-testing and blood testing; who receive assisted and unassisted self-testing. Moreover, it compares the proportion of taking confirmatory test out of those who receive the test in the assisted and unassisted self-testing; proportion of FSWs who receive HIV test out of those who got offered for the test (including self-testing) in the intervention group with proportion of FSWs who receive HIV test in the control group; the proportion of FSWs taking confirmatory test (including self-testing) out of those receive the test in intervention groups and control group. It compares, furthermore, the proportion of HIV positive in the assisted, unassisted (intervention) and HIV positive in the control group. This study also compares ART initiation in the assisted, unassisted (intervention) and the control group. Additionally, it compares stigma scores and FSWs who went to a health facility for HIV testing between assisted, unassisted group and compares the HIV and STI risk behaviors between assisted and unassisted group. It calculates, lastly, the cascade of HIV testing and treatment.

Conditions

Human Immunodeficiency Virus (HIV)

Keywords

Assisted community screening; Community based screening (CBS); Community HIV screening; Female sex worker (FSW); HIV self-testing; Human immunodeficiency virus (HIV); Oral fluid test (OFT); Outreach; Peer leader (PL); Unassisted community screening

Outcome Measures

Primary Outcomes (3)

• HIV testing uptake

  Number of FSWs receiving OFT and facility-based HIV testing, collected from OFT result (Annex 8) and blood test result (Annex 11).

  7 months

• HIV Positivity rate

  Proportion of HIV positive cases among all FSWs who receive facility-based HIV testing (including those who receive post-OFT confirmatory testing), collected through blood test result form (Annex 11).

  7 months

• Antiretroviral (ARV) initiation rate

  Proportion of FSWs with confirmed HIV positivity through facility-based testing (including post-OFT confirmatory tests) who initiate ARV treatment, collected through ARV initiation form (Annex 12).

  7 months

Secondary Outcomes (24)

• Age

  at enrollment

• Education

  at enrollment

• Marital status

  at enrollment

• Client source

  at enrollment

• Age of first sexual transaction

  at enrollment

Study Arms (1)

Female sex workers (FSW)

OTHER

Female sex workers (FSWs) community is the only group which has implemented the study intervention. This group has been underlined as the one of key affected populations (KAPs) that hold an increasing number of HIV incidence and prevalence recently in Indonesia even though it is approximately 226,791 FSWs by 2016 and around 5,254,065 clients access their services per year (MoH, 2017). The condition will be worst because the transmission definitely will continue to clients' sexual partner and moreover, their babies if their HIV status has not been known earlier. It means that lowering the transmission of HIV infection for FSWs, it will simultaneously lower its transmission to their sexual partners and furthermore their babies.

Diagnostic Test: HIV self-testing among female sex workers

Interventions

HIV self-testing among female sex workers DIAGNOSTIC_TEST

Barriers faced by FSWs in terms of undergoing HIV blood test seemingly overcome through the implementation of alternative strategy of testing, by using OFT self-testing (Ora-Quick). Ora-Quick test used in this study measures antibody in oral fluid of participants. The oral fluid is collected used a test swab from participant's gum by wiping upper and lower gums once. The specimen mixed with buffered developer solution in test tube. Test result will appear in a short time, by 20 to 40 minutes and leading to interpret.

Also known as: Community screening intervention

Female sex workers (FSW)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women, 18 years or older at enrollment
• Reports transactional sex (vaginal, oral and/or anal) at least once in the past month
• No HIV test in last 6 months
• Self-reported HIV negative OR HIV status unknown

You may not qualify if:

• Unwilling to participate for any reason
• Concurrently participating in another HIV prevention study

Sponsors & Collaborators

• Kerti Praja Foundation: lead
• United Nations: collaborator

Study Sites (1)

Kerti Praja Foundation

Denpasar, Bali, 80223, Indonesia

RECRUITING

Related Publications (20)

• King EJ, Maman S, Bowling JM, Moracco KE, Dudina V. The influence of stigma and discrimination on female sex workers' access to HIV services in St. Petersburg, Russia. AIDS Behav. 2013 Oct;17(8):2597-603. doi: 10.1007/s10461-013-0447-7.

  PMID: 23525789 BACKGROUND

• Napierala S, Desmond NA, Kumwenda MK, Tumushime M, Sibanda EL, Indravudh P, Hatzold K, Johnson CC, Baggaley RC, Corbett L, Cowan FM. HIV self-testing services for female sex workers, Malawi and Zimbabwe. Bull World Health Organ. 2019 Nov 1;97(11):764-776. doi: 10.2471/BLT.18.223560. Epub 2019 Sep 3.

  PMID: 31673192 BACKGROUND

• Nguyen VTT, Phan HT, Kato M, Nguyen QT, Le Ai KA, Vo SH, Thanh DC, Baggaley RC, Johnson CC. Community-led HIV testing services including HIV self-testing and assisted partner notification services in Vietnam: lessons from a pilot study in a concentrated epidemic setting. J Int AIDS Soc. 2019 Jul;22 Suppl 3(Suppl Suppl 3):e25301. doi: 10.1002/jia2.25301.

  PMID: 31321903 BACKGROUND

• Ortblad KF, Kibuuka Musoke D, Ngabirano T, Nakitende A, Taasi G, Barresi LG, Barnighausen T, Oldenburg CE. HIV self-test performance among female sex workers in Kampala, Uganda: a cross-sectional study. BMJ Open. 2018 Nov 8;8(11):e022652. doi: 10.1136/bmjopen-2018-022652.

  PMID: 30413504 BACKGROUND

• Shahmanesh M, Patel V, Mabey D, Cowan F. Effectiveness of interventions for the prevention of HIV and other sexually transmitted infections in female sex workers in resource poor setting: a systematic review. Trop Med Int Health. 2008 May;13(5):659-79. doi: 10.1111/j.1365-3156.2008.02040.x. Epub 2008 Feb 11.

  PMID: 18266784 BACKGROUND

• Shokoohi M, Karamouzian M, Khajekazemi R, Osooli M, Sharifi H, Haghdoost AA, Kamali K, Mirzazadeh A. Correlates of HIV Testing among Female Sex Workers in Iran: Findings of a National Bio-Behavioural Surveillance Survey. PLoS One. 2016 Jan 25;11(1):e0147587. doi: 10.1371/journal.pone.0147587. eCollection 2016.

  PMID: 26807584 BACKGROUND

• Johnston LG, Bonilla L, Caballero T, Rodriguez M, Dolores Y, de la Rosa MA, Malla A, Burnett J, Terrero V, Martinez S, Morgan O. Associations of HIV Testing, Sexual Risk and Access to Prevention Among Female Sex Workers in the Dominican Republic. AIDS Behav. 2017 Aug;21(8):2362-2371. doi: 10.1007/s10461-016-1616-2.

  PMID: 27896553 BACKGROUND

• Suthar AB, Ford N, Bachanas PJ, Wong VJ, Rajan JS, Saltzman AK, Ajose O, Fakoya AO, Granich RM, Negussie EK, Baggaley RC. Towards universal voluntary HIV testing and counselling: a systematic review and meta-analysis of community-based approaches. PLoS Med. 2013 Aug;10(8):e1001496. doi: 10.1371/journal.pmed.1001496. Epub 2013 Aug 13.

  PMID: 23966838 BACKGROUND

• Tokar A, Broerse JEW, Blanchard J, Roura M. HIV Testing and Counseling Among Female Sex Workers: A Systematic Literature Review. AIDS Behav. 2018 Aug;22(8):2435-2457. doi: 10.1007/s10461-018-2043-3.

  PMID: 29464430 BACKGROUND

• Tun W, Vu L, Dirisu O, Sekoni A, Shoyemi E, Njab J, Ogunsola S, Adebajo S. Uptake of HIV self-testing and linkage to treatment among men who have sex with men (MSM) in Nigeria: A pilot programme using key opinion leaders to reach MSM. J Int AIDS Soc. 2018 Jul;21 Suppl 5(Suppl Suppl 5):e25124. doi: 10.1002/jia2.25124.

  PMID: 30033680 BACKGROUND

• Wariki WM, Ota E, Mori R, Koyanagi A, Hori N, Shibuya K. Behavioral interventions to reduce the transmission of HIV infection among sex workers and their clients in low- and middle-income countries. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD005272. doi: 10.1002/14651858.CD005272.pub3.

  PMID: 22336811 BACKGROUND

• Reinius M, Wettergren L, Wiklander M, Svedhem V, Ekstrom AM, Eriksson LE. Development of a 12-item short version of the HIV stigma scale. Health Qual Life Outcomes. 2017 May 30;15(1):115. doi: 10.1186/s12955-017-0691-z.

  PMID: 28558805 BACKGROUND

• Wirtz AL, Pretorius C, Beyrer C, Baral S, Decker MR, Sherman SG, Sweat M, Poteat T, Butler J, Oelrichs R, Semini I, Kerrigan D. Epidemic impacts of a community empowerment intervention for HIV prevention among female sex workers in generalized and concentrated epidemics. PLoS One. 2014 Feb 6;9(2):e88047. doi: 10.1371/journal.pone.0088047. eCollection 2014.

  PMID: 24516580 RESULT

• Batona G, Gagnon MP, Simonyan DA, Guedou FA, Alary M. Understanding the intention to undergo regular HIV testing among female sex workers in Benin: a key issue for entry into HIV care. J Acquir Immune Defic Syndr. 2015 Mar 1;68 Suppl 2:S206-12. doi: 10.1097/QAI.0000000000000452.

  PMID: 25723986 RESULT

• Bengtson AM, L'Engle K, Mwarogo P, King'ola N. Levels of alcohol use and history of HIV testing among female sex workers in Mombasa, Kenya. AIDS Care. 2014;26(12):1619-24. doi: 10.1080/09540121.2014.938013. Epub 2014 Jul 21.

  PMID: 25040114 RESULT

• Deering KN, Montaner JS, Chettiar J, Jia J, Ogilvie G, Buchner C, Feng C, Strathdee SA, Shannon K. Successes and gaps in uptake of regular, voluntary HIV testing for hidden street- and off-street sex workers in Vancouver, Canada. AIDS Care. 2015;27(4):499-506. doi: 10.1080/09540121.2014.978730. Epub 2014 Nov 27.

  PMID: 25428563 RESULT

• Dugas M, Bedard E, Batona G, Kpatchavi AC, Guedou FA, Dube E, Alary M. Outreach strategies for the promotion of HIV testing and care: closing the gap between health services and female sex workers in Benin. J Acquir Immune Defic Syndr. 2015 Mar 1;68 Suppl 2:S198-205. doi: 10.1097/QAI.0000000000000463.

  PMID: 25723985 RESULT

• Hidayat R, Marguari D, Hairunisa N, Suparno H, Magnani R. Community HIV Screening Among MSM in Three Indonesian Cities. Curr HIV Res. 2019;17(1):65-71. doi: 10.2174/1570162X17666190321115419.

  PMID: 30907323 RESULT

• Kerrigan DL, Fonner VA, Stromdahl S, Kennedy CE. Community empowerment among female sex workers is an effective HIV prevention intervention: a systematic review of the peer-reviewed evidence from low- and middle-income countries. AIDS Behav. 2013 Jul;17(6):1926-40. doi: 10.1007/s10461-013-0458-4.

  PMID: 23539185 RESULT

• Yunus JO, Sawitri AAS, Wirawan DN, Mahendra IGAA, Susanti D, Utami Ds NKAD, Asanab D, Narayani IA, Mukuan OS, Widihastuti A, Magnani R, Januraga PP. Web-Based Multifaceted Approach for Community-Based HIV Self-Testing Among Female Sex Workers in Indonesia: Protocol for a Randomized Community Trial. JMIR Res Protoc. 2021 Jul 21;10(7):e27168. doi: 10.2196/27168.

  PMID: 34287217 DERIVED

Related Links

• Indonesia Factsheet, UNAIDS - 2016
• Karawita D.A. , Tennakoon S.U.B. , Suranga S. , Dissanayake M.S.W. Acceptability of Oral-fluid rapid HIV 1 and 2 antibody tes among selected key populations in Sri Lanka. Sri Lanka Journal of Sexual Health and HIV Medicine Volume 3.
• World Health Organization, Consolidated guidelines on HIV testing services. 2015. Geneva, Switzerland: WHO.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Anak Agung Sagung Sawitri, DR

  Kerti Praja Foundation

  PRINCIPAL INVESTIGATOR

• I G. A. A Mahendra, MPH

  Kerti Praja Foundation

  STUDY CHAIR

Central Study Contacts

Pande Putu Januraga, DrPH

CONTACT

0812-4618-0389; januraga@unud.ac.id

D. N. Wirawan, M.PH

CONTACT

0811-394-306; wirawandewa48@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Stratified randomization was carried out in 23 priority districts involved. Kind of HIV testing offered for FSW intervention group is difference with those, in control group. Both HIV blood test and self-testing are implemented in the intervention group while it is just HIV blood test provided for the control one. For assisted in the intervention group, FSW been reached is offered HIV blood test at least 3 times at stages of outreaching process, before answering the eligibility questions and before watching the guided OFT self-testing video. If she receives, she will be accompanied to take the test in health facilities. If she refuses, she will be offered to perform or continue to take OFT self-testing. For unassisted, FSW only has an option to undertake OFT self-testing. The FSW accesses the link on website (www.teman-kita.org) and registers herself independently without assistance of outreach workers (OW) who usually offer HIV blood test.

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: October 8, 2020
• Study Start: April 17, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)