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Evaluation of hepatitis B vaccine adherence among transgender women

Viral hepatitis A, B and C in a group of transgender women in Central Brazil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN60659382
Enrollment
285
Registered
2022-08-24
Start date
2018-04-25
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence to hepatitis B vaccine doses in healthy transgender women (TGW) Not Applicable

Interventions

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 eit
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).

Sponsors

Fundação de Amparo a Pesquisa do Estado de Goiás
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Persons who were found noticeably under the effects of psychoactive drugs (drunken and dopey) were excluded.

Design outcomes

Primary

MeasureTime frame
Adherence to at least three vaccine doses measured using patient records.

Secondary

MeasureTime frame
Immunogenicity of hepatitis B vaccine measured using anti-HBs titer measure following the third and fourth vaccine doses.

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026