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| Name | Class |
|---|---|
| Centre for Infectious Disease Research in Zambia | OTHER |
| Centers for Disease Control and Prevention | FED |
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This study seeks to evaluate the readiness of HIV-infected pregnant women in Zambia to initiate, adhere to, and be retained in care under the Ministry of Health's Option B+ policy. Under a 3-phased research study the investigators will: (1) conduct formative research regarding readiness to start lifelong ART in the pregnant population; (2) translate the results of formative research into a readiness assessment tool and an enhanced adherence package for pregnant women eligible for Option B+ and (3) conduct an individual randomized trial of the enhanced adherence package.
This is qualitative and quantitative research exploring the issues of patient readiness to initiate lifelong ART among HIV-infected pregnant women, as well as ART adherence and retention in HIV care and treatment during pregnancy and after delivery.
The objectives of Phase 1 of the study are as follows:
The objectives of Phase 2 of the study are as follows:
The objectives of Phase 3 of the study are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Other | The MOH-recommended approach is opt out HIV testing in pregnancy followed by immediate initiation of ART for HIV-infected pregnant women. ART initiation is accompanied with counseling geared to educate and prepare women to take up and be retained on ART lifelong. Women who do not return for clinical or drug refill visits are traced by phone or in person. |
|
| Enhanced adherence package | Experimental | The enhanced adherence package will be designed on the basis of the results of formative research. The intervention will support women who are eligible for ART under Option B+. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Adherence Package | Behavioral | The enhanced adherence package is yet to be designed, but may target all HIV-infected women with methods that are currently reserved only for late clients or clients of unknown status. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of women who both initiate ART and are retained in care | ART eligibility in the setting of Option B+ will generally be either the date of HIV diagnosis for pregnant women newly diagnosed with HIV infection during their antenatal care visit or the date of their first antenatal care visit for known HIV-infected pregnant women who are not already on ART | Within 30 days of eligibility to begin ART under Option B+ policy |
| HIV virologic suppression at time of delivery | Outcome of virologic suppression at delivery will be analyzed for differences between the SOC arm and intervention arm. | Time of delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Time from ART eligibility to ART initiation | Time from ART eligibility to initiation from enrollment until 6 months post-partum | |
| HIV transmission from mother to infant | At 6 weeks and 6 months of life |
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The criteria vary by study phase as follows:
Phase 1
Inclusion Criteria:
Exclusion Criteria:
Phase 2
Inclusion Criteria:
Phase 3
Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mwangelwa Mubiana, MBChB | Centre for Infectious Disease Research in Zambia | Principal Investigator |
| Benjamin Chi, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Michael J Vinikoor, MD | Centre for Infectious Disease Research in Zambia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Infectious Disease Research in Zambia | Lusaka | Zambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Millennium Development Goals Progress Report. 2011, Ministry of Finance and National Planning, UNDP: Lusaka. | ||
| Background | National HIV/AIDS/STIs/TB Council, 2009 HIV Epidemiological Projections Report. 2009: Zambia. | ||
| Background | Republic of Zambia Ministry of Health, National Protocol Guidelines Integrated Prevention of Mother-to-Child Transmission of HIV, Directorate of Public Health and Research, Editor. 2010, Ministry of Health: Lusaka, Zambia. | ||
| Background | Government of the Republic of Zambia, National Protocol Guidelines Integrated Prevention of Mother-to-Child Transmission of HIV/AIDS, M.o. Health, Editor. 2008: Lusaka. | ||
| 26180894 |
| Label | URL |
|---|---|
| University of North Carolina website | View source |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | Currently, the standard of care is based on the 2010 national HIV care and treatment guidelines, health care providers are encouraged to use a number of different means to improve ART adherence. |
|
| Background |
| Antiretroviral Drugs for Treating Pregnant Women and Preventing HIV Infection in Infants: Recommendations for a Public Health Approach: 2010 Version. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK304944/ |
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| Background | Government of the Republic of Zambia, Lifelong Antiretroviral Drugs (ARV's) for all HIV positive Pregnant Women in Zambia, M.o. Health, Editor. 2013: Lusaka. |
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| 33033996 | Derived | Mubiana-Mbewe M, Bosomprah S, Kadota JL, Koyuncu A, Kusanathan T, Mweebo K, Musokotwane K, Mulenga PL, Chi BH, Vinikoor MJ. Effect of Enhanced Adherence Package on Early ART Uptake Among HIV-Positive Pregnant Women in Zambia: An Individual Randomized Controlled Trial. AIDS Behav. 2021 Mar;25(3):992-1000. doi: 10.1007/s10461-020-03060-4. Epub 2020 Oct 8. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |