Evidence map›Paper›PMID 29133336›Full record

Trial reportBMJ open2017

Psychological, behavioural and physiological effects of three long-acting reversible contraception (LARC) methods: protocol for an ancillary study of the ECHO randomised trial.

Mandisa Singata-Madliki, G Justus Hofmeyr, Florence Carayon-Lefebvre d'Hellencourt, Theresa Anne Lawrie

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02550067 (A Multi Center, Open-Label, Randomised Clinical Trial Comparing HIV Incidence and Contraceptive Benefits in Women Using Depot Medroxyprogesterone Acetate), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.0field-weighted citation impact, top 16% 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.

NCT02550067 nacompletednot on this map

A Multi Center, Open-Label, Randomised Clinical Trial Comparing HIV Incidence and Contraceptive Benefits in Women Using Depot Medroxyprogesterone Acetate (DMPA), Levonorgestrel (LNG) Implant, and Copper Intrauterine Devices (IUDs)

TypeinterventionalSponsorFHI 360Ran2015 to 2018Enrolled7,830ConditionsHIV, ContraceptionArmsDMPA, LNG, Copper IUD
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Effects of three contraceptive methods on depression and sexual function: An ancillary study of the ECHO randomized trial.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2021
    Trial
  2. Trial
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

4 authors at 3 institutions in 3 countries.

Mandisa Singata-MadlikiEffective Care Research Unit (ECRU), East London Hospital Complex, University of Fort Hare, East London, South Africa.
G Justus HofmeyrEffective Care Research Unit (ECRU), East London Hospital Complex, University of Fort Hare, East London, South Africa.
Florence Carayon-Lefebvre d'HellencourtFHI 360, Durham, North Carolina, USA.
Theresa Anne LawrieEffective Care Research Unit (ECRU), East London Hospital Complex, University of Fort Hare, East London, South Africa.
University of Fort Hare · ZAFamily Health International 360 · USRoyal United Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis is the protocol for an ancillary study to the multicentre Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial, a three-arm randomised trial comparing the effects of depot medroxyprogesterone acetate (DMPA), the levonorgestrel (LNG) implant and the copper intrauterine device (IUD) on HIV incidence (NCT02550067 pre-results). The ancillary study will compare other non-contraceptive effects of these three long-acting, reversible contraceptions about which there is little existing comparative evidence. METHODS AND ANALYSIS: Women randomised to IUD, DMPA and LNG implant (1:1:1) at one of the ECHO trial sites will be asked to participate in the ancillary study at the 1-month follow-up visit. Research staff will interview women that consent to participate at the 3-month follow-up visit. Primary outcomes are depression, sexual dysfunction and menstrual disturbances. The Beck Depression Inventory will be used to assess depression and the Arizona Sexual Experiences Scale to assess sexual dysfunction. Participants will also be asked to prospectively complete a 28-day symptom diary. The required sample size is 522 participants. Depression scores will be analysed as continuous and categorical variables. Analysis will be by intention to treat. ETHICS AND DISSEMINATION: The ancillary study protocol received ethical approval from the University of the Witwatersrand Committee for Research on Human Subjects on 17 February 2016 (reference no. 14112). The results will be disseminated in a peer-reviewed open-access journal. TRIAL REGISTRATION NUMBER: PACTR201706001651380.

Indexed as

AdolescentAdultDepressionDysmenorrheaFemaleHumansIntrauterine Devices, CopperLevonorgestrelLondonLong-Acting Reversible ContraceptionMedroxyprogesterone AcetatePregnancyPregnancy, UnplannedResearch DesignSexual Dysfunction, PhysiologicalSouth AfricaLevonorgestrelMedroxyprogesterone Acetatecontraceptionintrauterine devicelong-acting progestogensexual dysfunction

Identifiers

PMID29133336
PMCPMC5695523
OpenAlexW2769885416

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.