HIV Awal (Early) Testing & Treatment Indonesia Project Observational Phase

NCT03429842 | Completed DMC

• 1 other identifier: The HATI Project HIV Phase 1
• Study Type: observational
• Target: 2,071
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will be one of the first to systematically evaluate strategies to improve the implementation of a T\&T strategy in a concentrated epidemic in Asia. While large controlled randomized trials assessing the efficacy of T\&T at the community level are underway, they are being run in the generalised epidemic settings of Africa with the population HIV prevalence above 15%. Findings on implementation of T\&T strategy from such settings will not be readily applicable to concentrated epidemics. This study will run in parallel with the trials so that the key implementation data in concentrated epidemic settings are available in a timely fashion. Finally, the study aims to develop capacity in implementation research in Indonesia. In line with principles of implementation science, the components of the intervention package will be designed from extensive discussions with all stakeholders including affected communities. This will ensure that the intervention is acceptable, feasible and could be integrated in to larger policy framework beyond the study. Further, the study will utilize and explore the role of primary care centres (Puskesmas) in providing 'Test and Treat' services. The success of T\&T strategy based on primary care model will be critical for the wider penetration of services to the key affected populations. It will generate key data on critical steps in the cascade of care and show how current prevention services might enhance the uptake of HIV testing and immediate treatment. The study will identify which programmatic areas, under current resources, need strengthening for a larger scale implementation of T\&T for HIV treatment and prevention. This will be a prospective implementation research study assessing the impact of enhanced community based interventions, on the uptake of HIV treatment and retention in care among key populations as part of a T\&T strategy in three urban settings in Indonesia. The enhanced package of interventions will be introduced in a series of steps over time. This phase 1- Pre-implementation of the enhanced intervention package (Year 1) Current standard practices for HIV treatment and care will be observed ('business as usual'), utilising a comprehensive data collection system at each participating site. In accordance with current national guidelines, all HIV positive participants will be offered immediate ART initiation after being diagnosed as HIV positive.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• Rates of virological suppression under current practice

  Number of participants viral load less than 50 copies/ml

  12 months

Secondary Outcomes (4)

• Uptake of HIV testing

  24 months

• Linkage between HIV testing and care

  24 months

• Uptake of ART among FSW, MSM and waria

  24 months

• Retention in treatment

  12 months

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adults from the following three key population groups: i) Gay men and other men who have sex with men (MSM) ii) Female sex workers, including brothel and non-brothel based sex workers (FSW) iii) Waria (transgender people)

You may qualify if:

• Newly diagnosis HIV Positive individual during the study observation period
• Aged 16 years and over
• Fow FSW : Had sex in exhange for money or a gft in the last 12 months or
• For MSM : Ever had sex with a man/waria
• For Waria : Identify as waria.

You may not qualify if:

• Unable to provide informed consent to enroll in the study
• Attending clinician judges that participation in the study would adversely affect individual.

Sponsors & Collaborators

• Gadjah Mada University: lead
• World Health Organization: collaborator
• Department of Foreign Affairs and Trade (DFAT), Australia: collaborator
• Kirby Institute: collaborator
• Hasan Sadikin General Hospital: collaborator
• Sardjito Hospital Yogyakarta: collaborator
• Yayasan Kerti Praja: collaborator
• Udayana University: collaborator
• Universitas Padjadjaran: collaborator
• Universitas Katholik Atmajaya: collaborator

Related Publications (28)

• Januraga PP, Wulandari LP, Muliawan P, Sawitri S, Causer L, Wirawan DN, Kaldor JM. Sharply rising prevalence of HIV infection in Bali: a critical assessment of the surveillance data. Int J STD AIDS. 2013 Aug;24(8):633-7. doi: 10.1177/0956462413477556. Epub 2013 Jul 19.

  PMID: 23970574 BACKGROUND

• Kotaki T, Khairunisa SQ, Sukartiningrum SD, Arfijanto MV, Utsumi T, Normalina I, Handajani R, Widiyanti P, Rusli M, Rahayu RP, Lusida MI, Hayashi Y, Nasronudin, Kameoka M. High prevalence of HIV-1 CRF01_AE viruses among female commercial sex workers residing in Surabaya, Indonesia. PLoS One. 2013 Dec 18;8(12):e82645. doi: 10.1371/journal.pone.0082645. eCollection 2013.

  PMID: 24367533 BACKGROUND

• Safika I, Johnson TP, Cho YI, Praptoraharjo I. Condom Use Among Men Who Have Sex With Men and Male-to-Female Transgenders in Jakarta, Indonesia. Am J Mens Health. 2014 Jul;8(4):278-88. doi: 10.1177/1557988313508430. Epub 2013 Nov 7.

  PMID: 24203992 BACKGROUND

• Mugglin C, Althoff NK, Wools-Kaloustian K, et al. Immunodeficiency at start of ART: A global view. 19th Conference on Retroviruses and Opportunistic Infections; 2012; Seattle, USA

  BACKGROUND

• Karim SS, Karim QA. Antiretroviral prophylaxis: a defining moment in HIV control. Lancet. 2011 Dec 17;378(9809):e23-5. doi: 10.1016/S0140-6736(11)61136-7. Epub 2011 Jul 21. No abstract available.

  PMID: 21771566 BACKGROUND

• Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR; HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493-505. doi: 10.1056/NEJMoa1105243. Epub 2011 Jul 18.

  PMID: 21767103 BACKGROUND

• Granich RM, Gilks CF, Dye C, De Cock KM, Williams BG. Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model. Lancet. 2009 Jan 3;373(9657):48-57. doi: 10.1016/S0140-6736(08)61697-9. Epub 2008 Nov 27.

  PMID: 19038438 BACKGROUND

• Kato M, Granich R, Bui DD, Tran HV, Nadol P, Jacka D, Sabin K, Suthar AB, Mesquita F, Lo YR, Williams B. The potential impact of expanding antiretroviral therapy and combination prevention in Vietnam: towards elimination of HIV transmission. J Acquir Immune Defic Syndr. 2013 Aug 15;63(5):e142-9. doi: 10.1097/QAI.0b013e31829b535b.

  PMID: 23714739 BACKGROUND

• Eaton JW, Johnson LF, Salomon JA, Barnighausen T, Bendavid E, Bershteyn A, Bloom DE, Cambiano V, Fraser C, Hontelez JA, Humair S, Klein DJ, Long EF, Phillips AN, Pretorius C, Stover J, Wenger EA, Williams BG, Hallett TB. HIV treatment as prevention: systematic comparison of mathematical models of the potential impact of antiretroviral therapy on HIV incidence in South Africa. PLoS Med. 2012;9(7):e1001245. doi: 10.1371/journal.pmed.1001245. Epub 2012 Jul 10.

  PMID: 22802730 BACKGROUND

• Severe P, Juste MA, Ambroise A, Eliacin L, Marchand C, Apollon S, Edwards A, Bang H, Nicotera J, Godfrey C, Gulick RM, Johnson WD Jr, Pape JW, Fitzgerald DW. Early versus standard antiretroviral therapy for HIV-infected adults in Haiti. N Engl J Med. 2010 Jul 15;363(3):257-65. doi: 10.1056/NEJMoa0910370.

  PMID: 20647201 BACKGROUND

• Kitahata MM, Gange SJ, Abraham AG, Merriman B, Saag MS, Justice AC, Hogg RS, Deeks SG, Eron JJ, Brooks JT, Rourke SB, Gill MJ, Bosch RJ, Martin JN, Klein MB, Jacobson LP, Rodriguez B, Sterling TR, Kirk GD, Napravnik S, Rachlis AR, Calzavara LM, Horberg MA, Silverberg MJ, Gebo KA, Goedert JJ, Benson CA, Collier AC, Van Rompaey SE, Crane HM, McKaig RG, Lau B, Freeman AM, Moore RD; NA-ACCORD Investigators. Effect of early versus deferred antiretroviral therapy for HIV on survival. N Engl J Med. 2009 Apr 30;360(18):1815-26. doi: 10.1056/NEJMoa0807252. Epub 2009 Apr 1.

  PMID: 19339714 BACKGROUND

• Lockman S, Sax P. Treatment-for-prevention: clinical considerations. Curr Opin HIV AIDS. 2012 Mar;7(2):131-9. doi: 10.1097/COH.0b013e32834fcf6b.

  PMID: 22227588 BACKGROUND

• Writing Committee for the CASCADE Collaboration. Timing of HAART initiation and clinical outcomes in human immunodeficiency virus type 1 seroconverters. Arch Intern Med. 2011 Sep 26;171(17):1560-9. doi: 10.1001/archinternmed.2011.401.

  PMID: 21949165 BACKGROUND

• When To Start Consortium; Sterne JA, May M, Costagliola D, de Wolf F, Phillips AN, Harris R, Funk MJ, Geskus RB, Gill J, Dabis F, Miro JM, Justice AC, Ledergerber B, Fatkenheuer G, Hogg RS, Monforte AD, Saag M, Smith C, Staszewski S, Egger M, Cole SR. Timing of initiation of antiretroviral therapy in AIDS-free HIV-1-infected patients: a collaborative analysis of 18 HIV cohort studies. Lancet. 2009 Apr 18;373(9672):1352-63. doi: 10.1016/S0140-6736(09)60612-7. Epub 2009 Apr 8.

  PMID: 19361855 BACKGROUND

• Suthar AB, Lawn SD, del Amo J, Getahun H, Dye C, Sculier D, Sterling TR, Chaisson RE, Williams BG, Harries AD, Granich RM. Antiretroviral therapy for prevention of tuberculosis in adults with HIV: a systematic review and meta-analysis. PLoS Med. 2012;9(7):e1001270. doi: 10.1371/journal.pmed.1001270. Epub 2012 Jul 24.

  PMID: 22911011 BACKGROUND

• Forsyth AD, Valdiserri RO. Reaping the prevention benefits of highly active antiretroviral treatment: policy implications of HIV Prevention Trials Network 052. Curr Opin HIV AIDS. 2012 Mar;7(2):111-6. doi: 10.1097/COH.0b013e32834fcff6.

  PMID: 22227586 BACKGROUND

• Garnett GP, Becker S, Bertozzi S. Treatment as prevention: translating efficacy trial results to population effectiveness. Curr Opin HIV AIDS. 2012 Mar;7(2):157-63. doi: 10.1097/COH.0b013e3283504ab7.

  PMID: 22258503 BACKGROUND

• Bendavid E, Brandeau ML, Wood R, Owens DK. Comparative effectiveness of HIV testing and treatment in highly endemic regions. Arch Intern Med. 2010 Aug 9;170(15):1347-54. doi: 10.1001/archinternmed.2010.249.

  PMID: 20696960 BACKGROUND

• Gardner EM, McLees MP, Steiner JF, Del Rio C, Burman WJ. The spectrum of engagement in HIV care and its relevance to test-and-treat strategies for prevention of HIV infection. Clin Infect Dis. 2011 Mar 15;52(6):793-800. doi: 10.1093/cid/ciq243.

  PMID: 21367734 BACKGROUND

• Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.

  PMID: 21091279 BACKGROUND

• Uy J, Armon C, Buchacz K, Wood K, Brooks JT; HOPS Investigators. Initiation of HAART at higher CD4 cell counts is associated with a lower frequency of antiretroviral drug resistance mutations at virologic failure. J Acquir Immune Defic Syndr. 2009 Aug 1;51(4):450-3. doi: 10.1097/QAI.0b013e3181acb630.

  PMID: 19474757 BACKGROUND

• Bastard M, Fall MB, Laniece I, Taverne B, Desclaux A, Ecochard R, Sow PS, Delaporte E, Etard JF. Revisiting long-term adherence to highly active antiretroviral therapy in Senegal using latent class analysis. J Acquir Immune Defic Syndr. 2011 May 1;57(1):55-61. doi: 10.1097/QAI.0b013e318211b43b.

  PMID: 21775934 BACKGROUND

• Birger RB, Hallett TB, Sinha A, Grenfell BT, Hodder SL. Modeling the impact of interventions along the HIV continuum of care in Newark, New Jersey. Clin Infect Dis. 2014 Jan;58(2):274-84. doi: 10.1093/cid/cit687. Epub 2013 Oct 17.

  PMID: 24140971 BACKGROUND

• Peters DH, Adam T, Alonge O, Agyepong IA, Tran N. Implementation research: what it is and how to do it. BMJ. 2013 Nov 20;347:f6753. doi: 10.1136/bmj.f6753. No abstract available.

  PMID: 24259324 BACKGROUND

• Padian NS, Holmes CB, McCoy SI, Lyerla R, Bouey PD, Goosby EP. Implementation science for the US President's Emergency Plan for AIDS Relief (PEPFAR). J Acquir Immune Defic Syndr. 2011 Mar 1;56(3):199-203. doi: 10.1097/QAI.0b013e31820bb448. No abstract available.

  PMID: 21239991 BACKGROUND

• Sohn AH, Srikantiah P, Sungkanuparph S, Zhang F. Transmitted HIV drug resistance in Asia. Curr Opin HIV AIDS. 2013 Jan;8(1):27-33. doi: 10.1097/COH.0b013e32835b804f.

  PMID: 23196932 BACKGROUND

• Widyanthini DN, Januraga PP, Wisaksana R, Subronto YW, Sukmaningrum E, Kusmayanti NA, Dewi H, Law M, Kaldor JM, Wirawan DN. HIV self-testing for men who have sex with men: an implementation trial in Indonesia. AIDS Care. 2022 Apr;34(4):527-534. doi: 10.1080/09540121.2021.1883509. Epub 2021 Feb 8.

  PMID: 33550846 DERIVED

• Januraga PP, Reekie J, Mulyani T, Lestari BW, Iskandar S, Wisaksana R, Kusmayanti NA, Subronto YW, Widyanthini DN, Wirawan DN, Wongso LV, Sudewo AG, Sukmaningrum E, Nisa T, Prabowo BR, Law M, Cooper DA, Kaldor JM. The cascade of HIV care among key populations in Indonesia: a prospective cohort study. Lancet HIV. 2018 Oct;5(10):e560-e568. doi: 10.1016/S2352-3018(18)30148-6. Epub 2018 Aug 22.

  PMID: 30143455 DERIVED

Related Links

• UNAIDS. UNAIDS Report on the global AIDS epidemic. 2012
• UNAIDS. HIV in Asia and the Pacific:Getting to zero. 2011
• World Health Organization (WHO). Antiretroviral Treatment as Prevention (TasP) of HIV and TB. 2012
• UNAIDS. Indonesia's Minister of Health promises to transform the national response to AIDS. 2012

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

• Dewa N Wirawan, Prof

  Universitas Udayana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr, MPH

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 12, 2018
• Study Start: September 15, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 19, 2018

Record last verified: 2018-02