1. HIV Prevalence and Incidence Estimates Among Women with High Risk Indicators in Addis Ababa, Ethiopia Asfawesen G-Yohanes 1, Stephanie Combes 2, Abraham Aseffa 1, Pai-Lien Chen 2, Paul Feldblum 2, Shelly Fischer 2 Dominick Shattuck 2, Altaye Kidane 2 1.Armauer Hansen Research Institute, ALERT Center, Addis Ababa, Ethiopia 2.Family Health International 360, Durham, United States 3.Family Health International 360, Addis Ababa, Ethiopia

2. Overview – The need for clinical trial sites for HIV prevention research – Criteria for successful development – Collaboration in Ethiopia – Cross-sectional HIV incidence study in Addis Ababa – Parallel BED False Recent study

3. Introduction: Need for HIV Prevention Clinical Trial Sites Promising results from HIV prevention trials – Male circumcision – Topical microbicide, Tenofovir gel – Oral pre-exposure prophylaxis Continuing need for new clinical trial sites – USAID and FHI360 project to develop trial sites – Site Identification and Development Initiative (SIDI)

4. Dimensions of successful capacity building Trained staff Clinical infrastructure Laboratory infrastructure Data management capacity Supportive administration HIV prevention as part of government priorities

5. FHI 360 and AHRI collaboration Armauer Hansen Research Institute (AHRI) is the research arm of ALERT Center Has MOH support for conducting research FHI360 & AHRI worked together to increase the clinical trial capacity at AHRI – Hired & trained staff – Increased laboratory and data management capacity – Conducted a GCP compliant HIV Incidence study

6. Cross-sectional HIV Incidence Study Recruited women at higher risk of HIV infection using modified Respondent Driven sampling method Eligibility criteria: – 18 – 35 years old – > 2 heterosexual sex acts per week and/or – > 2 partners in the previous one month Data collected: – Baseline demographics – Medical history – Sexual behaviors – HIV and pregnancy testing Syndromic STI treatment provided, if indicated Estimated incidence ( Recent Infection) using BED-CEIA assay

7. Parallel BED False Recent Study BED-CEIA assay tends to overestimate the number of incident infections Need to measure the local false recent rate (correction factor) Enrolled women and men who: – Ages 18-35 – Documented as HIV-positive for at least 12 months – No history of ART (including Nevirapin) BED testing to find proportion who falsely show as recently infected

8. Results - Enrollment 1865 women enrolled in cross-sectional phase – 1855 underwent HIV testing using parallel rapid testing – HIV positive samples tested with the BED assay 574 enrolled in BED false recent phase – 504 women with 431 tested – 70 men with 55 tested

9. Cross-sectional Phase Demographics Participant profileParticipant statistics Young:75% — less than 24 years old; mean age 21.5; median age 20 Poorly educated:43% — no education 25% — primary education Unemployed:95% — reported work status as “unemployed” 95% — described themselves as “sex workers” Single:77% — not married Most lived with others: 72% — lived with friends 11% — lived with family 16% — lived alone Large income variation: 273.26 Ethiopian birr (ETB) — average weekly income (= US$23.92) 75% — earned less than 340 ETB per week (= US$29.76)

10. Region of Birth

11. Cross-sectional: High Risk Behavior & FP 94% of participants had >5 partners in the last month 2.5% had sex with an HIV infected partner in the last month Some form of contraception used by 90% of women – 35% used condoms only – 42% used injectables – 14% used pills

12. Pregnancy Prevalence of 5.9% Higher occurrence of pregnancies among – Condom users (9.5%) – Pill users (3.7%)

13. HIV Prevalence Prevalence: 11.3% Higher prevalence among older women (aged > 25 years) – 26.5% vs 7.9%

14. Predictors of HIV prevalence In logistic regression analysis, 3 indicators were most predictive of HIV prevalence: – Being older (> 25 years old): OR = 4.4 – Presence of STI symptoms: OR = 2.4 – Having unprotected sex (no condom) in previous 7 days: OR = 1.5

15. HIV Incidence Adjusted incidence: 2.7% [1.7% - 3.6%] Incidence by age group is similar 18-24 Yrs: 2.5% 25-35 Yrs: 3.0%

16. Conclusions One of first studies in Ethiopia to specifically measure HIV incidence Incidence is high enough to justify HIV prevention trials Age, STI symptoms, & recent unprotected sex are greatest risk factors for prevalent infections Family planning is another reproductive health need Large sub-group of women at higher risk of HIV in this section of Addis AHRI well placed for future prevention research & programming

17. Acknowledgements SIDI Team at AHRI Addis Ababa City Admin Health Bureau Kolfe Keranyo Subcity Administration, Wereda and Kebele Offices ALERT, Zwditu M, St Paul and Yekatit 12 Hospitals Wereda 23, 24, 25 Health Centers HAPCSO FHI360-NC: Connie Sexton** FHI 360-Ethiopia: Francesca Stuer