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| ID | Type | Description | Link |
|---|---|---|---|
| K01MH100994 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| UZ-UCSF Collaborative Research Programme | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
| Gilead Sciences | INDUSTRY |
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This is a prospective, non-randomized, open-label study to look at the uptake, adherence to, and impact of pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART), semen washing, and vaginal insemination to prevent HIV among HIV-discordant couples attempting conception in Zimbabwe.
The reproductive needs of HIV-discordant couples who desire pregnancy represent an urgent public health problem that has been neglected in HIV prevention research. In Zimbabwe , and across sub-Saharan Africa, the vast majority of HIV-infected individuals are adults of reproductive age. Pregnancy and the desire for children are common among HIV-infected individuals, and HIV-discordant couples face a difficult choice between attempting pregnancy and risking HIV transmission to their partners. Recent surveys have found that 30-50% of HIV-infected individuals in sub-Saharan Africa are involved in stable, HIV-discordant relationships, and HIV transmission within married, cohabitating HIV-discordant couples accounts for 44-60% of new HIV infections in some regions of sub-Saharan Africa. While knowledge of HIV discordance can lead to increased condom use, many discordant couples have unprotected intercourse often motivated by the desire to conceive. Currently, HIV discordant couples who attempt to conceive place themselves at considerable risk of transmission. This research study aims to help promote couples' rights to conceive while at the same time decreasing the risk of HIV transmission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV+male/HIV-female | discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or semen washing |
| |
| HIV+female/HIV-male | discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or artificial vaginal insemination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEP (Truvada) | Drug | oral, daily Truvada for HIV-negative participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of safer conception strategies | proportion of couples choosing the strategy | 12 months |
| Acceptability of safer conception strategies | proportion of couples remaining on strategy; reports of satisfaction | 12 months |
| Adherence to safer conception strategies | proportion of couples with high adherence to strategy | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of safer conception strategies on HIV prevention | incidence of HIV | 12 months |
| Effectiveness of safer conception strategies on achieving pregnancy | incidence of pregnancy |
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Inclusion Criteria:
For all couples:
For HIV-uninfected members of the couple
For HIV-infected members of the couple
Exclusion Criteria:
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HIV-discordant couples in Harare, Zimbabwe who are trying to get pregnant
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| Name | Affiliation | Role |
|---|---|---|
| Joelle M Brown, PhD, MPH | University of California, San Francisco | Principal Investigator |
| Felix Mhlanga, MBChB, MMed | UZ-UCSF Collaborative Research Programme | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZCHS-UCSF CTRC Zengeza Clinical Research Site | Harare | Zimbabwe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36963004 | Derived | Brown JM, Gitome S, Mataveke B, Chirenda T, Matubu A, Chareka G, Chasakara C, Mgodi N, Murombedzi C, Musara P, Makurumure T, Hughes CS, Bukusi E, Cohen CR, Shiboski S, Darbes L, Kahn JG, Rutherford GW, Chirenje ZM, Mhlanga F. Preventing HIV and achieving pregnancy among HIV sero-different couples: Pilot study of a safer conception intervention in Zimbabwe. PLOS Glob Public Health. 2023 Feb 24;3(2):e0000796. doi: 10.1371/journal.pgph.0000796. eCollection 2023. | |
| 33046066 |
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De-identified data will be made available at the end of the study on an online repository.
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D044966 | Anti-Retroviral Agents |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Antiretrovirals | Drug | oral daily antiretrovirals and frequent viral load monitoring for HIV-positive participant |
|
|
| Semen washing | Procedure | collection of semen from an HIV-positive man, processing semen to remove HIV, followed by intrauterine insemination |
|
| Artificial vaginal insemination | Procedure | collection of semen from an HIV-negative man, followed by intravaginal insemination |
|
| 12 months |
| costs of providing safer conception services | costs | 12 months |
| cost-effectiveness of safer conception strategies | model the cost effectiveness of various combinations of safer conception strategies | 12 months |
| Hughes CS, Brown J, Murombedzi C, Chirenda T, Chareka G, Mhlanga F, Mateveke B, Gitome S, Makurumure T, Matubu A, Mgodi N, Chirenje Z, Kahn JG. Estimated costs for the delivery of safer conception strategies for HIV-discordant couples in Zimbabwe: a cost analysis. BMC Health Serv Res. 2020 Oct 12;20(1):940. doi: 10.1186/s12913-020-05784-4. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D000068679 |
| Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D000998 | Antiviral Agents |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |