Reaching the Unreached Service Uptake and Retention Among

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Reaching the Unreached Service Uptake and Retention Among Marginalized Populations Workshop Wednesday 20 th

Reaching the Unreached Service Uptake and Retention Among Marginalized Populations Workshop Wednesday 20 th July 11: 00 am – 12: 30 pm #AIDS 2016 | @AIDS_conference

Understanding the underserved: Minorities within the majority Ingrid T. Katz, MD, MHS Assistant Professor,

Understanding the underserved: Minorities within the majority Ingrid T. Katz, MD, MHS Assistant Professor, Harvard Medical School Associate Physician, Brigham & Women’s Hospital Research Scientist, Center for Global Health, Massachusetts General Hospital #AIDS 2016 | @AIDS_conference

Disclosure • I have no financial conflicts of interest • I receive salary and

Disclosure • I have no financial conflicts of interest • I receive salary and research support from: – Connors Center for Women’s Health and Gender Biology – Burke Fellowship – Harvard University Center for AIDS Research – National Institute of Mental Health • K 23 MH 097667 • R 34 MH 10839301 #AIDS 2016 | @AIDS_conference

Key points for synergy • Understanding how “Key Populations” may mean different things in

Key points for synergy • Understanding how “Key Populations” may mean different things in different contexts • “Key” - refers to specific or heightened vulnerabilities and 'risks' in terms of HIV • Ultimately need to create programs and interventions that address this risk/vulnerability through addressing individual / social / structural factors #AIDS 2016 | @AIDS_conference

Goals for this Presentation • Gaps and losses in care throughout the pre-ART and

Goals for this Presentation • Gaps and losses in care throughout the pre-ART and early-ART phases of the continuum in South Africa • Defining this key population: Individuals presenting for testing who do not initiate ART – What is Treatment Refusal • Data from our recent cohort analyses: Defining key populations and discussing risk factors • Where to go from here: The Treatment Ambassador Program #AIDS 2016 | @AIDS_conference

GAPS IN CARE #AIDS 2016 | @AIDS_conference

GAPS IN CARE #AIDS 2016 | @AIDS_conference

Treatment Coverage for HIV-infected Individuals in Sub-Saharan Africa by Percent, 2010 #AIDS 2016 |

Treatment Coverage for HIV-infected Individuals in Sub-Saharan Africa by Percent, 2010 #AIDS 2016 | @AIDS_conference Source: Katz IT et al, New Engl and Journal of Medicine, 2013

CD 4 Trends in ART Initiation in Sub. Saharan Africa 2002 -2013 #AIDS 2016

CD 4 Trends in ART Initiation in Sub. Saharan Africa 2002 -2013 #AIDS 2016 | @AIDS_conference Siedner M, Ng C, Bassett IV, Katz IT, Bansgberg D, Tsai AC, CID, 2015

Test and Treat Strategy #AIDS 2016 | @AIDS_conference. Source: UNICEF, 2014

Test and Treat Strategy #AIDS 2016 | @AIDS_conference. Source: UNICEF, 2014

DEFINING THE KEY POPULATION #AIDS 2016 | @AIDS_conference

DEFINING THE KEY POPULATION #AIDS 2016 | @AIDS_conference

20% of Adults Presenting for Voluntary Counseling and for. Testing (VCT) in Soweto Testing

20% of Adults Presenting for Voluntary Counseling and for. Testing (VCT) in Soweto Testing in Soweto Refused Treatment Source: Katz IT et al, AIDS, 2011 #AIDS 2016 | @AIDS_conference

Understanding treatment refusal among adults presenting for HIVtesting in Soweto, South Africa: a qualitative

Understanding treatment refusal among adults presenting for HIVtesting in Soweto, South Africa: a qualitative study #AIDS 2016 | @AIDS_conference Katz IT et al, AIDS Behav, 2015

Risks Perceived in Starting Treatment Losing health or beauty “They said, ‘You are HIV

Risks Perceived in Starting Treatment Losing health or beauty “They said, ‘You are HIV positive, ’ and I said, ‘I am not HIV positive. ’ [. . . ] I told myself that I am beautiful and they say I am HIV positive. Are they sick? I said, no, they are mad. How can they say that? I am very healthy. ” − Female, Sustained Refuser #AIDS 2016 | @AIDS_conference

Risks Perceived in Starting Treatment Stigma associated with disclosure “In a rural area, it’s

Risks Perceived in Starting Treatment Stigma associated with disclosure “In a rural area, it’s a small place even though you trust the nurses and stuff like that. People who are in the clinic, they know that you go to that door when you are HIV positive. You come in this way, so they will notice, ‘Wow, she is HIV positive. ’ So they will start talking. ” #AIDS 2016 | @AIDS_conference − Female, Initial Refuser

Risks Perceived in Starting Treatment Increased Financial Burdens “My problem is that sometimes I

Risks Perceived in Starting Treatment Increased Financial Burdens “My problem is that sometimes I do not have food to eat at all. How can I take [ARVs] when I don’t have food to eat? So now that means that I will default, but if I knew that I had money then I would take them. ” − Female, False Acceptor #AIDS 2016 | @AIDS_conference

Protective Factors Offsetting Risks of Starting Treatment Coping, Resilience and the importance of Social

Protective Factors Offsetting Risks of Starting Treatment Coping, Resilience and the importance of Social Support “In rural areas, we have fields where there is no one. I went there and wrote a suicidal letter. It was addressed to my grandmother and aunts. But then I thought of people who love me. I thought my teacher wouldn't’t like this. She wouldn't’t be proud of me, because she knows that I am a fighter. I am a hardworker, and if I do this she will be disappointed. I just cried and then said, let me just pull myself together. I lost my mother. I got shot and survived. So why am I not going to survive this HIV thing? ” #AIDS 2016 | @AIDS_conference − Female, Initial Refuser

COHORT ANALYSIS #AIDS 2016 | @AIDS_conference

COHORT ANALYSIS #AIDS 2016 | @AIDS_conference

Prospective Cohort Study • Determine rates of ART refusal among PLWH at the point

Prospective Cohort Study • Determine rates of ART refusal among PLWH at the point of eligibility and over a 6 month period • Assessed modifiable socio-behavioral factors associated with treatment refusal and viral load suppression #AIDS 2016 | @AIDS_conference

Study Sites: Soweto and Gugulethu #AIDS 2016 | @AIDS_conference

Study Sites: Soweto and Gugulethu #AIDS 2016 | @AIDS_conference

Participant Eligibility • Recruitment – 500 ART-eligible participants between July 2014 and June 2015

Participant Eligibility • Recruitment – 500 ART-eligible participants between July 2014 and June 2015 – ART eligibility changed during study • Pre-Jan 2015: CD 4 ≤ 350 cells/mm 3 • Jan 2015: CD 4 ≤ 500 cells/mm 3 • Pregnant women and children excluded #AIDS 2016 | @AIDS_conference

The Theory of Triadic Influence: Informing Measure Selection Domain Individual Factors Measure • Self-assessed

The Theory of Triadic Influence: Informing Measure Selection Domain Individual Factors Measure • Self-assessed health • Self-efficacy • Coping skills • Fatalism • Denial Social Factors • Social support • Social norms • Perceived stigma Structural Factors • Access to care • Perceived quality of care • Food insecurity #AIDS 2016 | @AIDS_conference Outcome Primary: Rates of ART Refusal at baseline, 3 months and 6 months Secondary: • Factors associated with ART refusal • HIV-1 RNA suppression at six months

Study Recruitment 1071 adults presented for VCT and eligible for ART 360 (34%) lost

Study Recruitment 1071 adults presented for VCT and eligible for ART 360 (34%) lost after testing [Median CD 4: 194] [IQR: 160– 355] 711 (66%) presented for CD 4 results [Median CD 4: 262] [IQR: 141– 372] 500 enrolled in study #AIDS 2016 | @AIDS_conference

Baseline Characteristics Variable Total (n=500) Median Age 35 years Female 63 % Median CD

Baseline Characteristics Variable Total (n=500) Median Age 35 years Female 63 % Median CD 4 + 244 cells/mm 3 Unemployed 57% Repeat testers 62% Repeat testers with a prior positive test #AIDS 2016 | @AIDS_conference 60%

Baseline (point of testing) • 6. 6% of ART-eligible individuals who presented for testing

Baseline (point of testing) • 6. 6% of ART-eligible individuals who presented for testing reported they were not planning to start treatment. • Significantly higher odds of fatalistic beliefs #AIDS 2016 | @AIDS_conference

Multivariable Model of Factors Associated ART Refusal at Baseline, stratified by social support (n=483)*

Multivariable Model of Factors Associated ART Refusal at Baseline, stratified by social support (n=483)* Low Social Support n=133 High Social Support n=350 Variable Adjusted 95% CI Odds Ratio Adjusted Odds Ratio 95% CI Age ≥ 35 1. 49 0. 35— 6. 30 1. 20 0. 47— 3. 07 Baseline CD 4 < 350 1. 02 0. 22— 4. 81 1. 31 0. 39— 4. 34 Less High School Education 1. 66 0. 25— 11. 17 1. 08 0. 29— 3. 97 Female Gender 1. 11 0. 22— 5. 47 0. 96 0. 36— 2. 53 Denial 0. 75 0. 48— 1. 16 0. 90— 1. 49 Stigma 1. 32 0. 84— 2. 08 1. 14 0. 88— 1. 47 Fatalism 1. 40 1. 05— 1. 86 1. 12 0. 96— 1. 30 * n=483 due to seventeen participants refusal to answer questions on social support, #AIDS 2016 | @AIDS_conference coping, stigma, or fatalism

Treatment Refusal • At 6 months: – 1. 8% (n=9) died within 6 months

Treatment Refusal • At 6 months: – 1. 8% (n=9) died within 6 months – 44. 4% (n=222) had yet to initiate • Verified through the National Health Laboratory Service or clinic records • Perceptions of low ART efficacy was significantly associated with sustained refusal #AIDS 2016 | @AIDS_conference

Viral Load Suppression • Ultimately, only 25% of our cohort (125 participants) were virally

Viral Load Suppression • Ultimately, only 25% of our cohort (125 participants) were virally suppressed within nine months of learning eligibility. • Participants who refused ART at 6 months were significantly more likely to be unable to suppress their viral load at 9 months (p<0. 001) • #AIDS 2016 | @AIDS_conference

Long-term outcome • Low rates of viral load suppression among this high-risk key population

Long-term outcome • Low rates of viral load suppression among this high-risk key population • Treatment refusal is significantly associated with a lack of viral load suppression #AIDS 2016 | @AIDS_conference

WHERE TO GO FROM HERE #AIDS 2016 | @AIDS_conference

WHERE TO GO FROM HERE #AIDS 2016 | @AIDS_conference

Treatment Ambassador Program (TAP) #AIDS 2016 | @AIDS_conference

Treatment Ambassador Program (TAP) #AIDS 2016 | @AIDS_conference

Thank You #AIDS 2016 | @AIDS_conference • David Bangsberg, Glenda Gray, Catherine Orrell, Norma

Thank You #AIDS 2016 | @AIDS_conference • David Bangsberg, Glenda Gray, Catherine Orrell, Norma Ware, Laura Bogart, Ingrid Bassett, Janan Dietrich, Marya Gwadz, Garrett Fitzmaurice, Kathy Goggin • From MGH Center for Global Health & the Connors Center for Gender Biology • RAs: Holly Zanoni, Dominick Leone, Ingrid Courtney, Gugu Tshabalala • Funders: NIMH, Burke Family, CFAR, Mike Stirratt (Program Officer) • Participants: From the Republic of South Africa