The experience with. carehpvin El Salvador

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1 The experience with carehpvin El Salvador

2 I am a trainer for the Merck contraception, Nexplanon I have no commercial relationship with any organization or company that sells HPV testing products Basic Health International has an agreement with the Ministry of Health of El Salvador, to oversee the donation program for the QIAGENcares carehpv implementation program

3 Established in 1997 NGO Founded in 2005 Vision: Eradicate Cervical Cancer in Latin America and the Caribbean Mission: To provide women with low cost screening and treatment Direct patient care, training, research, policy implementation

4 carehpv DNA-based testing used for HPV More accurate than pap, less frequent screening Operates in volatile conditions Self-sampling option

5 3 phase program Phase 1: - October March ,000 women, 4 municipalities / main health clinics - Goal: Defining a treatment algorithm Phase 2: - October 2013 June ,000 women, 6 municipalities, 37 additional health houses or community clinics - Goal: Systems improvement Phase 3: - September 2014 July ,000 women, 1/5 of country - Goal: Regional scale-up, Full National MOH take-over (2016)

6 2,000 women Determine most effective follow-up method for women carehpv+ 4 health centers involved Target population: - women no history of screening in > 3 years 2 cohorts

7 Cohort A Self Sampling and Provider Sample HPV-positive Results in 2 weeks HPV-Negative Screen in 5 years Refer to Colposcopy clinic Colpo / Biopsy Treatment Colpo Negative HPV in 1 year

8 Cohort B Self Sample and Provider Sample HPV positive Results in 2 weeks Visual Triage HPV Negative Screen in 5 years Treatable with Cryo or no lesion Receive treatment Not treatable with cryo Refer to Colpo

9 Education / Training / Capacity Building This is KEY for program success Every person touches new technology needs to understand it HPV Basic Knowledge Health Promoters Nurses Physicians (both GP and OB/GYNs) Administrative personnel Lab personnel Introduction of New technology / Test Administrative Regulations Customs Regulations Transportation and Storage

10 Training Health Promoters

11 Training Administrative Personnel

12 Training Nurses / Physicians

13 Information System Started new information system to have better Monitoring and Evaluation

14 Information System Trained technical personnel on new system

15 Equipment Pictures of equipment seen in presentations Luminometer Heater/ Shaker Control panel

16 Equipment carehpv machine in our clinic

17 Training Lab Personnel Trained 3 laboratory technicians

18 Laboratory Lab technician can run 2 batches per day

19 Education Sessions Women attend educational sessions

20 Education Sessions Women attend educational sessions

21 Group Counseling Nurses and physicians counseling women before their screening

22

23

24 At 6 Month Follow-up Average time between results and colpo= 50 days 93 HPV-positive (9.3%) 1000 women screened 905 HPV-negative (90.7%) (will rescreen in 5 years) 100% received results and made appointment for colposcopy 82/93 women attended colposcopy (88.2%) 11 did not attend colposcopy (11.8%) 4 had normal impression with no biopsies taken (5%) 2 had negative biopsy(2%) PRELIMINARY RESULTS PLEASE DO NOT COPY, CITE, OR DISTRIBUTE 82/82 Received proper follow up / treatment Women with treatment 88.2% Average time between biopsy and treatment= 48 days

25 At 6 Month Follow-up 1000 women screened 119 HPV-positive (11.9%) 881 HPV-negative (88.1%) (will rescreen in 5 years) 8 judged ineligible for cryotherapy and referred to colposcopy (6.7%) 111 treated with cryotherapy (93.3%) 8 referred to colposcopy and received treatment PRELIMINARY RESULTS PLEASE DO NOT COPY, CITE, OR DISTRIBUTE Women with treatment 100% (119/119)

26 Local Pathologist TOTAL % Quality Control Review % Normal 2 2.5% % CIN % 5 6.7% CIN % % CIN % % AIS 0 0.0% 2 2.6% CIN % %

27 Self-sampling is accepted by the majority of women (68%) Many combinations of preferences for place and method of sampling only (1/3 have no preference) We observed good concordance between provider and self-collected sampling

28 Screening with carehpv provides greater health benefits than current Pap smear screening. Routine screening with carehpv (every 5y) is costeffective compared to Pap testing (every 2y) at a costeffectiveness threshold of 1x-3x GDP per capita. Screening with carehpv followed by visual triage (cohort B) is more effective and less costly than carehpv with colposcopy triage (cohort A).

29 8,000 women Determine most effective follow-up method for women carehpv+ 12 health centers involved Target population: - women 30-49

30 Educated / Trained 202 health promoters

31 Educated / Trained 81 nurses

32 Educated / Trained 46 physicians

33 Average time between results and colpo= > 50 days 351 HPV-positive (12.7%) 2767 women screened 2416 HPV-negative (87.3%) (will rescreen in 5 years) 282/351 (80%) of HPV received results and made appointment for colposcopy 169/282 (60%) have attended colposcopy 10 did not attend colposcopy (10.7%) 162/169 (96%) Received proper follow up / treatment Average time between biopsy and treatment= >48 days PRELIMINARY RESULTS PLEASE DO NOT COPY, CITE, OR DISTRIBUTE Women treated, 46% (162/351)

34 2809 women screened 356 HPV-positive (11.3%) 2,453 HPV-negative (88.7%) (will rescreen in 5 years) 29/356 judged ineligible for cryotherapy and referred to colposcopy (8.15%) 257/356 treated with cryotherapy (72.19%) 70/356 waiting for response (19.66%) PRELIMINARY RESULTS PLEASE DO NOT COPY, CITE, OR DISTRIBUTE Women treated 80% (286/351)

35

36 20,000 women Determine most effective follow-up method for women carehpv+ VISUAL TRIAGE / COHORT B Regional Implementation Target population: - Women Women Strengthen Information System Establish CME and QC for pathology

37 Primary HPV testing in low resource settings is feasible Screen and treat is more clinically- and cost-effective than colposcopy management Self sampling good option and increases total screened NGO/Government/private sector partnerships can be mutually beneficial

38 Any questions?

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