Evaluation of hepatitis B vaccine adherence among transgender women
| ISRCTN | ISRCTN60659382 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60659382 |
| Secondary identifying numbers | 77481417.5.0000.5083, 201.710.267.000.536 |
- Submission date
- 19/08/2022
- Registration date
- 24/08/2022
- Last edited
- 29/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The Brazilian health surveillance system does not collect data on gender identity. Studies on viral hepatitis among trans gender women (TGW) are scarce, and there is no data on hepatitis B vaccination. Therefore, this study aimed to estimate the prevalence of hepatitis A, B, and C among TGW in Central Brazil. In addition, we compared the adherence and immunogenicity of two hepatitis B vaccine schedules to contribute to public health for this socially marginalized population.
The purpose of this study was to estimate the prevalence of viral hepatitis A, B, and C in three cities in Goiás (goiânia, Itumbiara e Jataí), Central Brazil, and compare the adherence and immunogenicity of two hepatitis B vaccine schedules among transgender women (TGW) in Goiânia.
Who can participate?
Persons who self-defined as transgender women and presented a valid RDS coupon and report no hepatitis B vaccine doses previously or don't know her vaccine status.
What does the study involve?
A total of 440 participants were interviewed and tested for hepatitis A virus, hepatitis B virus, and hepatitis C virus markers during 2017-2018. Of 285 TWG recruited in Goiânia, 230 denied previous hepatitis B vaccine and were invited and accepted to receive hepatitis B vaccine doses. They were randomized to receive a super accelerated hepatitis B vaccine schedule (G1) vs. a standard schedule (G2). The adherence and immunogenicity of hepatitis B vaccine were evaluated among women who received at least three vaccine doses.
What are the possible benefits and risks of participating?
Benefits: being vaccinated against hepatitis B and thus being immunized against this infection that causes a disease of high morbidity and mortality.
Risks: the hepatitis B vaccine has been available in Brazil since the late 1990s and is offered free to the entire population. Its effectiveness is widely known. However, the interval between doses has been a problem for the completeness of the regimen, and several accelerated regimens have been tested and proposed, as in this study. Therefore, the risks of participating in this study are low and the same as if they had been vaccinated in public or private immunization services and limited to local adverse reactions such as pain and swelling at the injection site and systemic reactions such as fever (the most common) and allergic reactions.
Where is the study run from?
Fundação de Amparo a Pesquisa do Estado de Goiás (FAPEG) (Brazil)
When is the study starting and how long is it expected to run for?
March 2017 to January 2020
Who is funding the study?
Fundação de Amparo a Pesquisa do Estado de Goiás (FAPEG) (Brazil)
Who is the main contact?
Sheila A. Teles, sateles@ufg.br
Contact information
Principal Investigator
Rua T 38, n. 1097 apto 201
Goiânia
74223042
Brazil
 ORCID ID |
0000-0002-7059-4241 |
|---|---|
| Phone | +55-62999215006 |
| sateles@ufg.br |
Study information
| Study design | Interventional randomized parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | 42260 PIS.pdf |
| Scientific title | Viral hepatitis A, B and C in a group of transgender women in Central Brazil |
| Study objectives | A higher adherence to hepatitis B vaccine dose using a super accelerated scheme when compared to the conventional scheme |
| Ethics approval(s) | Approved 17/10/2018, Ethics Committee for Human Research of the Universidade Federal de Goiás (Prédio da Reitoria Térreo Cx. Postal 131, Campus Samambaia. 74.001-970. Brazil; +55-62-35211215; cep.prpi.ufg@gmail.com), ref: 77481417.5.0000.5083 |
| Health condition(s) or problem(s) studied | Adherence to hepatitis B vaccine doses in healthy transgender women (TGW) |
| Intervention | The study included 230 TGW who reported no previous hepatitis B or were unaware of their hepatitis B vaccination status in a hepatitis B vaccination cohort. They were randomly recruited to receive either a super accelerated scheme (G1; four doses at 0, 7, 21, and 180 days) or a standard scheme (G2; three doses at 0, 1, and 4 months). Vaccine doses of 20 µg of recombinant HBsAg were administered into the deltoid muscle (Serum Institute of India PVT. LTD; lots 03560L24 and 03560L72). |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | Hepatitis B vaccine. Serum Institute of India PVT. LTD; lots 03560L24 and 03560L72 |
| Primary outcome measure | Adherence to at least three vaccine doses measured using patient records. |
| Secondary outcome measures | Immunogenicity of hepatitis B vaccine measured using anti-HBs titer measure following the third and fourth vaccine doses. |
| Overall study start date | 01/03/2017 |
| Completion date | 23/01/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 285 |
| Total final enrolment | 230 |
| Key inclusion criteria | 1. Self-defined as transgender women 2. Present valid RDS coupon 3. Report no hepatitis B vaccine doses previously or don't know her vaccine status |
| Key exclusion criteria | Persons who were found noticeably under the effects of psychoactive drugs (drunken and dopey) were excluded. |
| Date of first enrolment | 25/04/2018 |
| Date of final enrolment | 27/08/2019 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Goiânia
74605-080
Brazil
Sponsor information
Government
Rua Dona Maria Joana (travessa da AV. 83), 150
Goiânia
74.083-140
Brazil
| Phone | +55 (62) 3623-0400 |
|---|---|
| atendimento.fapeg@goias.gov.br | |
| Website | http://www.fapeg.go.gov.br/ |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Research Support Foundation of the State of Goiás, Foundation for Research Support of the State of Goiás, Goiás State Research Support Foundation, FAPEG
- Location
- Brazil
Results and Publications
| Intention to publish date | 30/10/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 23/08/2022 | No | Yes | ||
| Results article | 27/09/2023 | 29/12/2023 | Yes | No |
Additional files
Editorial Notes
29/12/2023: Publication reference added.
23/08/2022: Trial's existence confirmed by Ethics Committee for Human Research of the Universidade Federal de Goiás
