Evidence map›Paper›PMID 33060086›Full record

ArticleBMJ open2020

Couples-based approach to HIV prevention for transgender women and their partners: study protocol for a randomised controlled trial testing the efficacy of the 'It Takes Two' intervention.

Kristi E Gamarel, Jae M Sevelius, Torsten B Neilands, Rachel L Kaplan, Mallory O Johnson, Tooru Nemoto, Lynae A Darbes, Don Operario

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04067661 naterminatednot on this map

A Couples-Based Approach to HIV Prevention for Transgender Women and Their Male Partners

TypeinterventionalSponsorUniversity of MichiganRan2019 to 2024Enrolled104ConditionsHIV Infections, HIV Primary InfectionArmsCHIP, Control
NCT06639932 narecruitingnot on this mapstarted 2025, after this paper: background citation

Evaluating the Effects of the We-INtervention Among Chinese HIV-serodiscordant Male Couples in a Randomized Controlled Trial

TypeinterventionalSponsorCity University of Hong KongRan2025 to 2027Enrolled320ConditionsHIVArmsWe-INtervention, Usual Care Group
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

Kristi E GamarelDepartment of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.
Jae M SeveliusCenter for AIDS Prevention Studies, University of California, San Francisco, California, USA.
Torsten B NeilandsCenter for AIDS Prevention Studies, University of California, San Francisco, California, USA.
Rachel L KaplanDepartment of Obstetrics, Gynecology, & Reproductive Sciences, University of California, San Francisco, California, USA.
Mallory O JohnsonCenter for AIDS Prevention Studies, University of California, San Francisco, California, USA.
Tooru NemotoPublic Health Institute, Oakland, California, USA.
Lynae A DarbesDepartment of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor, Michigan, USA.
Don OperarioDepartment of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA Don_Operario@brown.edu.ORCID 0000-0003-2467-5048
University of California, San Francisco · USBrown University · USMichigan Department of Health and Human Services · USPublic Health Institute · USUniversity of Michigan · US

Funding

Scientific/Technical CoreP2CHD041028 · NICHD · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Sarah A. Burgard · 2017 to 2026
$6.5M
Training Program for Scientists Conducting Research to Reduce HIV Health DisparitR25MH067127 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Emily A Arnold, Torsten Brian Neilands · 2003 to 2026
$5.4M
A couples-based approach to HIV prevention for transgender women and their male partnersR01MH115765 · NIMH · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI GAMAREL, KRISTI E, OPERARIO, DON · 2018 to 2022
$2.9M
NICHD NIH HHS P2C HD041028NIMH NIH HHS R01 MH115765NIMH NIH HHS R25 MH067127
6 · The paper itself

Abstract

introductionHIV transmission and acquisition risk among transgender women is particularly high in the context of primary partnerships. This project extends a previous pilot couples-focused HIV intervention programme, which was shown to be feasible, acceptable and promising in reducing sexual risk behaviour among transgender women and their partners. This randomised controlled trial (RCT) tests the efficacy of this culturally sensitive HIV prevention programme for HIV-serodiscordant and HIV-negative seroconcordant transgender women and their partners. METHODS AND ANALYSIS: To finalise the protocol for trial, we used qualitative methods to hone eligibility criteria, refine the intervention and control manuals, and name and brand the intervention ('It Takes Two'). The RCT investigates the effects of the It Takes Two intervention on Composite Risk for HIV (CR-HIV) among 100 couples. CR-HIV is a binary indicator of couple HIV risk using validated measures of sexual behaviour, pre-exposure prophylaxis use among HIV-negative participants and viral suppression among participants living with HIV. Using a two-arm RCT, we will examine intervention effects on CR-HIV at 12-month follow-up comparing transgender women and their partners randomised to the intervention versus control (HIV prevention information only). ETHICS AND DISSEMINATION: This study has been reviewed and approved by the University of California, San Francisco (19-28624) and the University of Michigan (HUM00147690) Institutional Review Boards. Participants provide informed consent before taking part of the study activities. Results will be published in peer-reviewed journals and presented at scientific conferences. We will make our results available to the community of researchers and general public interested in transgender health to avoid unintentional duplication of research, as well as to others in the health and social services community, including LGBT community-based organisations, AIDS service organisations and other transgender-serving organisations. The full de-identified dataset and codebook will be shared at the University of Michigan Digital Repository. TRIAL REGISTRATION NUMBER: NCT04067661.

Indexed as

Acquired Immunodeficiency SyndromeHIV InfectionsTransgender PersonsTranssexualismFemaleHumansMaleRandomized Controlled Trials as TopicSan FranciscoHIV & AIDSmental healthpublic health

Identifiers

PMID33060086
PMCPMC7566735
OpenAlexW3093079220

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.