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Strategies to improve adherence and acceptability of hormonal methods of contraception

  1. Vera Halpern1,
  2. Laureen M Lopez1,*,
  3. David A Grimes2,
  4. Laurie L Stockton3,
  5. Maria F Gallo4

Editorial Group: Cochrane Fertility Regulation Group

Published Online: 26 OCT 2013

Assessed as up-to-date: 4 SEP 2013

DOI: 10.1002/14651858.CD004317.pub4


How to Cite

Halpern V, Lopez LM, Grimes DA, Stockton LL, Gallo MF. Strategies to improve adherence and acceptability of hormonal methods of contraception. Cochrane Database of Systematic Reviews 2013, Issue 10. Art. No.: CD004317. DOI: 10.1002/14651858.CD004317.pub4.

Author Information

  1. 1

    FHI 360, Clinical Sciences, Research Triangle Park, North Carolina, USA

  2. 2

    University of North Carolina, School of Medicine, Obstetrics and Gynecology, Chapel Hill, North Carolina, USA

  3. 3

    FHI360, Health Services Research, Research Triangle Park, North Carolina, USA

  4. 4

    The Ohio State University, Division of Epidemiology, Columbus, Ohio, USA

*Laureen M Lopez, Clinical Sciences, FHI 360, PO Box 13950, Research Triangle Park, North Carolina, NC 27709, USA. llopez@fhi360.org.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 26 OCT 2013

SEARCH

 
Characteristics of included studies [ordered by study ID]
Berenson 2012

MethodsLocation: Southeast Texas (USA); enrollment from Jul 2006 to Jan 2010.

Sample size calculation (and outcome of focus): N=190 in each group (570 total) for 90% power to detect OR of 2.0 for oral contraceptive (OC) continuation after 12 months.


ParticipantsGeneral with N: 1155 women, 16 to 24 years of age

Source: 5 public clinics for reproductive health serving low income women.

Inclusion criteria: sexually active, non-pregnant females, 16 to 24 years old, requesting OC initiation.

Exclusion criteria: desire to become pregnant in next year, medical contraindication to OC, current or prior (>1 month) OC use.


Interventions1) Counseling plus phone (C+P): counseling (below) plus phone calls by contraceptive counselor (weekly until initiation then monthly for 6 months) and access to 24-hour toll-free number;

2) Counseling (C): standard care plus 45 minutes of contraceptive counseling from study staff;

3) Standard care from nurse practitioner with written protocol for new OC users.
Duration: 6-month intervention; telephone follow up at 3, 6 and 12 months


OutcomesOC adherence (consistent OC use), pregnancy (self-report and medical record review)


NotesLosses to follow up by 12 months: 44% counseling, 43% counseling + phone, and 45% standard care.

Exclusions after randomization: none apparent


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated randomization scheme (PLAN procedure, SAS Institute)

Allocation concealment (selection bias)High riskWhen asked about concealment before assignment, investigator communicated that they did not conceal it from the researchers but did conceal it from the patient.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskSingle-blinded study; staff who made assessment phone calls were blinded to intervention group.

Canto De Cetina 2001

MethodsMethods of randomization are not reported.
One site at 'Centro de Investigaciones Hideyo Noguchi,' Merida, Yucatan (Mexico).


Participants350 women attending the Family Planning Clinic and willing to use DMPA for contraception. Inclusion criteria were: between the ages of 18 and 35 years old, living in a rural area; proven fertility; regular menstrual cycles during the previous six months; not breastfeeding; at least one child; normal PAP smear; willing to use DMPA as the only contraceptive agent during the course of the study; willing to return to the clinic every three months. Exclusion criteria were: current or history of thrombophlebitis; thromboembolic disorders; hypertension; cerebral vascular disease; active or chronic liver disease; known or suspected breast or genital organ malignancy; endocrinopathy undiagnosed; vaginal bleeding; diabetes mellitus.


InterventionsStructured pre-treatment and follow-up counseling versus routine pre-treatment counseling.

Follow-up visits coincided with injection time, which was every 3 months for 1 year.


OutcomesCumulative life table discontinuation rate, reason for discontinuation, DMPA-induced side effects.


NotesLosses to follow up: Counseling group, 1%; Control group, 2%.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskns

Allocation concealment (selection bias)Unclear riskns

Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot clear if blinding of investigators and evaluators of the study outcomes was maintained

Castaño 2012

MethodsLocation: Brooklyn, NY (USA); enrollment from March 2008 to July 2009

Sample size calculation (and outcome of focus): detect 10% change in OC continuation between groups, assuming 40% continuation at 6 months in routine-care group; N=480 needed in each group.


ParticipantsGeneral with N: 962 women younger than 25 years
Source: family planning health center

Inclusion criteria: sexually active; owned a cell phone with text messaging functionality; no medical contraindications to oral contraceptive use.


Interventions1) Routine care, including contraceptive counseling and handout.

2) Routine care plus 180 daily text messages (reminders to take OC daily; short education messages addressing 6 domains of OC knowledge: risks, benefits, side effects, use, effectiveness, and mechanisms of action). Message length < 160 characters.

Participants were followed for six months.


OutcomesOC continuation (participant had taken pill during the last 7 days) assessed by phone at 6 months after enrollment.

Also missed pills, interruptions in OC use > 7 days, use of OC at last sexual intercourse.


NotesLosses to follow up: 28% for treatment and 30% for control.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom number table used with blocks of four.

Allocation concealment (selection bias)Low riskOpaque, sequentially-numbered, sealed envelopes. Investigators masked to allocation while randomizing.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskNone used

Gilliam 2004

MethodsOne site at Northwestern Memorial Hospital, Chicago, IL (USA); 1998 to 1999.


Participants33 African American low-income females attending Prentice Ambulatory Care. This resident-run clinic serves low-income women receiving public assistance. Inclusion criteria: 25 years or younger; with unplanned pregnancy; intending to use OCs postpartum. Exclusion criterion: history of consistent or successful oral contraceptive (OC) use prior to pregnancy.


InterventionsUsual care: Prior to discharge, all participants received the standard postpartum counseling. Residents discussed how to take the pill, what to do if a pill is missed, side effects and risks and benefits of OCs. Participants received three labeled pill packets with instructions and phone numbers for 24-hour access if they had questions.

Experimental intervention: Antepartum, multi-component intervention consisting of counseling, videotape about OCs, and written material.

Participants were followed for one year.


OutcomesContinuation rate at one year, switch to other contraceptives at one year;

pregnancy rate at one year for 9 women (from delivery records or self-report).


NotesKnowledge of OCs mentioned, but data reported elsewhere. 43 women were enrolled in the Chicago study but only 33 were randomized. Reasons for study enrollment without randomization included participants changing their mind about using OCs, delivering at an outside hospital, and failure of the study team to randomize the participant prior to leaving the hospital due to miscommunication with nursing staff or leaving after a 24-hour rather than 48-hour stay.

Losses to follow up: by 1 year, 52% dropped out. Pregnancy data were obtained on 9 of the women that dropped out via records or contacting participant, leaving data loss for 8/33 = 24%.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated random numbers table; randomized following delivery

Allocation concealment (selection bias)Low riskStudy packets were in envelopes that "concealed the contents"

Blinding (performance bias and detection bias)
All outcomes
Low riskResearch team members were reportedly blind to group participation; details not provided.

Hou 2010

MethodsFamily planning clinic in Boston, MA (USA).
Intervention lasted 3 months.
Sample size calculation based on data from an earlier study: ability to detect 1.6-pill improvement with two-sided test at 90% power.


Participants82 women seeking care at the clinic. Inclusion criteria: personal mobile phone with text-messaging capabilities and desire to use OC for at least 6 months
Exclusion criteria: contraindication to OC use, use of OC primarily for non-contraceptive indications, current use of OC for more than 1 month, intent of pregnancy in the next 12 months, plans to travel outside the cell phone networks of USA and Canada during the study, inability to complete the study, and being in situation in which receipt of a text-message reminder to take OC would endanger the safety and privacy of the woman


InterventionsDaily text message to remember to take OC; control did not receive reminders.


OutcomesNumber of missed pills per cycle, measured with electronic monitoring device and diary


NotesLosses to follow up: reportedly 12% for treatment and 10% for control.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated with varying block sizes of 4 and 6

Allocation concealment (selection bias)Low riskOpaque, sequentially-numbered envelopes; did not state whether envelopes were sealed.

Blinding (performance bias and detection bias)
All outcomes
Low riskInvestigator-blinded

Jay 1984

MethodsOne site of the Title V Children and Youth Project for the State of Georgia (USA).


Participants57 adolescents attending adolescent gynecology clinic and were willing to use oral contraceptives.


InterventionsPeer versus nurse counseling at three appointments for both groups.

Participants were followed for four months.


OutcomesNoncompliance measured by a Guttman scale consisting of 1) avoidance of pregnancy, 2) appointment adherence, 3) pill count, 4) urinary fluorescence for riboflavin.
Second outcome was attrition rate at four months (end of study); defined as failing to keep the second rescheduled broken appointment or discontinuing the oral contraceptive regimen.


Notes31 (54%) subjects were assigned to the nurse-counselor group, and 26 (46%) were assigned to the peer-counselor group. 50% (28 or 29) of the participants were expected to be assigned to each group. A sampling error of this degree was not significant with a sample size of 57.
Losses to follow up: 33% overall; nurse-counseled, 42%; peer-counseled, 23%


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated random numbers table

Allocation concealment (selection bias)Unclear riskns

Blinding (performance bias and detection bias)
All outcomes
Low riskUrine samples for fluorescence were evaluated in a double-blind fashion by 3 independent observers

Keder 1998

MethodsOne site at the Magee-Womens Hospital clinic in Pittsburgh, PA (USA).


Participants250 women attending the clinic and willing to use DMPA for contraception. Inclusion criteria were access to a telephone and planning to return to the same facility for continuing care. Exclusion criteria were currently receiving depot medroxyprogesterone treatment, planning to undergo tubal ligation, immediately postpartum, unwilling to provide back-up contact information.


InterventionsMail and telephone reminders of the next injection two weeks before each scheduled injection versus written appointment card.

Participants were followed for 12 months.


OutcomesDiscontinuation rate at 12 months, rate of on-time injections, reason for discontinuation, DMPA-induced side effects.


NotesAn injection received within 14 weeks of the prior injection was classified as 'on-time' injection.
Losses to follow up: according to data provided by researcher, 36% overall; reminder group, 39%; no reminder group, 33%. The report had noted 17.6% loss for the year-end interview.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated randomization list

Allocation concealment (selection bias)Unclear riskns

Blinding (performance bias and detection bias)
All outcomes
High riskWomen enrolled were told of their assignment; researchers not blinded.

Kirby 2010

MethodsLocation: San Francisco, CA (USA)
Sample size calculation (and outcome of focus): 80% chance of finding 10-percentage-point difference in proportion of women who used hormonal contraception for 6 months or longer


ParticipantsGeneral with N: 805 females, 14 to 18 years old
Source: reproductive health clinic for adolescents and young adults
Inclusion criteria: not pregnant or trying to become pregnant, had sex in the last 3 months, no consistent hormonal contraception for 3 months and no IUD or contraceptive implant
Exclusion criteria: ns


InterventionsStudy focus: improve contraceptive use, reduce unintended pregnancy and STI
Treatment: Intense phone follow-up after initial visit (9 calls planned) using motivational interviewing
Comparison or control: regular clinic services
Duration: 12 months


OutcomesCorrect use of hormonal contraceptive (injectable, patch, OC), self-reported pregnancy


NotesLosses to follow up: reported as 22% at 6 months, 25% at 18 months; reportedly did not differ by group


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskrandom number generator; participants were stratified by age

Allocation concealment (selection bias)Unclear riskns

Blinding (performance bias and detection bias)
All outcomes
Low risksingle blind (outcome assessor)

Trent 2013

MethodsLocation: Baltimore, MD (USA); Jan 2011 to Mar 2012.


ParticipantsGeneral with N: 100 urban adolescent girls

Source: urban academic practice

Inclusion criteria: age 13 to 21 years, willing to be randomized, currently using DMPA, have cellular phone with text messaging capability for personal use.

Exclusion criteria: using other forms of contraception, do not have cell phone with text messaging capability for personal use.


Interventions1) Intervention: starting 72 hours before clinical visit, daily text appointment reminders; monthly healthy self-management messages during enrollment period (condom used, weight control, side effect management, STD testing reminder); call for missed appointment or no reply to appointment reminder (or other text message).

2) Standard care: counseling and clinic appointment reminders; call from nurse case manager after missing scheduled re-injection appointment

Duration: 3 injection cycles


OutcomesAppointment adherence by 9 months (3 injection appointments)


NotesInformation obtained from published abstract, ClinicalTrials.gov listing, and communication with investigator. Trial was recently finished; full paper was being submitted.

Eighty-seven percent of participants completed all 3 DMPA cycles.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated randomization sequence, according to investigator's communication

Allocation concealment (selection bias)Low riskRandomization concealed prior to assignment, according to investigator's communication. Research staff opened a packet, which contained randomization status and pertinent information for next steps in the study.

Blinding (performance bias and detection bias)
All outcomes
Unclear riskPI was blinded to patient's enrollment status (single blind), according to investigator's communication

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Andolsek 1982Outcome measures were not limited to hormonal methods, but rather grouped hormonal and non-hormonal methods.

Behboodi 2013The study was 'quasi-experimental.' Investigator communicated that one of two health centers in the city was assigned as the case group, which received BASNEF model classes. The other health center was assigned as control group and they had routine education. Study is reportedly complete and a paper is undergoing peer-review for a journal.

Bender 2004Did not evaluate any outcomes relevant to this review.

Burnhill 1985Intervention was individualized and did not focus on hormonal methods.

Carneiro 2011Not specific to hormonal methods; included condoms and IUDs (in general).

Gilliam 2010Two study arms assigned to different contraceptive methods; however, both received the same reminders.

Langston 2010Outcome was continuation of very effective or effective method. 'Very effective' was a combination of non-hormonal and hormonal methods (sterilization, IUDs, implants).

Madden 2013Not a randomized controlled trial.

Metson 1991Not a randomized controlled trial.

Roye 2007Women could be using one of several hormonal contraceptives. Intervention focused on condom use for HIV prevention.

Schunmann 2006Not a randomized controlled trial; used alternate assignment.

Schwandt 2013No relevant outcome measure (knowledge and intention to use). Intervention did not focus on hormonal methods.

Schwarz 2008Control group was given information on folate supplementation, but no family planning counseling.

Westhoff 2010Outcome not relevant to this review (choice of contraceptive on enrollment day)

Zhu 2009Analysis of pregnancy grouped all types of contraceptives and no method use. For OCs, 'regular use' was not defined, though counts were provided.

 
Characteristics of ongoing studies [ordered by study ID]
Smith 2013

Trial name or titleMobile Technology for Improved Family Planning (MOTIF)

MethodsLocation: 4 clinics in Cambodia

RCT, single blind (outcome assessor); evaluate effectiveness of voice-based mobile phone health (mHealth) intervention to support post-abortion family planning (PAFP)

ParticipantsEstimated enrollment: 500 women, aged 18 years and older

Inclusion criteria: attending for abortion, doesn't want to have a child at current time, age >= 18 years, owns mobile phone, willing to receive simple voice messages relating to contraception in Khmer language.

Interventions1) Mobile phone-based intervention: standard care (below) plus automated voice message to support post-abortion contraception use every two weeks, and follow up phone call by family planning counselor depending on response to voice message.

2) Standard care: face-to-face post-abortion family planning (PAFP) counseling, follow up
at one or two weeks, clinic phone number, existing 'Hotline' phone number.

Duration: 3 months; outcomes assessed at 4 months post-abortion

OutcomesPrimary: self-reported use of pill, coil, implant or injection for all participants;

objective measurement of contraceptive use for participants from one clinic (no detail).

Secondary: pregnancy, repeat abortion, and contraceptive discontinuation.

Starting dateMay 2013; estimated completion Dec 2013

Contact informationChris GJ Smith, MBBCh MSc; +85589421536; christopher.smith@lshtm.ac.uk

Notes

 
Comparison 1. Peer counseling versus nurse counseling

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Non-compliance (Guttman score) at four months138Mean Difference (IV, Fixed, 95% CI)-0.21 [-0.88, 0.46]

 2 Attrition at four months157Odds Ratio (M-H, Fixed, 95% CI)0.42 [0.13, 1.32]

 
Comparison 2. Multicomponent intervention versus routine counseling

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Continuation of oral contraceptives at one year133Odds Ratio (M-H, Fixed, 95% CI)1.14 [0.21, 6.16]

 2 Switched contraceptives by one year133Odds Ratio (M-H, Fixed, 95% CI)3.2 [0.67, 15.38]

 3 Loss to follow up133Odds Ratio (M-H, Fixed, 95% CI)0.3 [0.06, 1.51]

 
Comparison 3. Counseling + phone calls versus counseling versus standard care

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Consistent OC use: counseling + phone versus counseling1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 At 3 months
1767Odds Ratio (M-H, Fixed, 95% CI)1.41 [1.06, 1.87]

    1.2 At 12 months
1767Odds Ratio (M-H, Fixed, 95% CI)1.12 [0.78, 1.61]

 2 Consistent OC use: counseling versus standard care1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    2.1 At 3 months
1771Odds Ratio (M-H, Fixed, 95% CI)0.81 [0.61, 1.07]

    2.2 At 12 months
1771Odds Ratio (M-H, Fixed, 95% CI)0.89 [0.62, 1.27]

 3 Pregnancy (by 12 months)1Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    3.1 Counseling + phone versus counseling
1767Odds Ratio (M-H, Fixed, 95% CI)0.80 [0.53, 1.18]

    3.2 Counseling versus standard care
1771Odds Ratio (M-H, Fixed, 95% CI)1.39 [0.93, 2.09]

 
Comparison 4. Structured counseling versus routine counseling

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Discontinuation by 6 months1350Odds Ratio (M-H, Fixed, 95% CI)0.36 [0.20, 0.64]

 2 Discontinuation by 12 months1350Odds Ratio (M-H, Fixed, 95% CI)0.27 [0.16, 0.44]

 3 Discontinuation due to menstrual disturbances1350Odds Ratio (M-H, Fixed, 95% CI)0.20 [0.11, 0.37]

 4 Discontinuation due to other medical reasons1350Odds Ratio (M-H, Fixed, 95% CI)0.84 [0.36, 1.92]

 5 Lost to follow up1350Odds Ratio (M-H, Fixed, 95% CI)0.66 [0.11, 4.02]

 
Comparison 5. Daily text-message reminders versus no reminders

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Mean number of missed pills (cycle 1)173Mean Difference (IV, Fixed, 95% CI)0.5 [-1.08, 2.08]

 2 Mean number of missed pills (cycle 3)173Mean Difference (IV, Fixed, 95% CI)0.80 [-1.22, 2.82]

 
Comparison 6. Daily educational text messages versus no messages

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 OC use (continuation) at 6 months1683Odds Ratio (M-H, Fixed, 95% CI)1.54 [1.14, 2.10]

 2 No OC interruptions > 7 days (by 6 months)1683Odds Ratio (M-H, Fixed, 95% CI)1.53 [1.13, 2.07]

 
Comparison 7. Intensive reminders versus written appointment cards

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Discontinuation at 12 months1250Odds Ratio (M-H, Fixed, 95% CI)1.11 [0.67, 1.82]

 2 On-time injections of those who continued DMPA1110Odds Ratio (M-H, Fixed, 95% CI)0.75 [0.22, 2.63]

 3 On-time injections overall1250Odds Ratio (M-H, Fixed, 95% CI)0.87 [0.52, 1.44]

 4 Loss to follow up1250Odds Ratio (M-H, Fixed, 95% CI)1.26 [0.75, 2.12]

 
Table 1. Correct use of contraceptives: motivational phone calls versus usual care (Kirby 2010)

Outcome1N6 months18 months


Effect sizeP valueEffect sizeP

Correct use of DMPA: injection on schedule in last 3 months (% yes)1271.900.341.700.42

Correct use of patch: patch stayed on for week during last month (% yes)1520.950.750.600.74

Correct use of patch: applied new patch each week for 3 weeks,
then waited a week (during last month (% yes))
1530.860.950.570.72

Correct use of pill: number of pills missed last month308-0.010.940.070.56

 1Investigators provided these results from adjusted multivariate analyses.
 
Table 2. Results by quality of evidence

StudyRandomization
and allocation
concealment
No objective
outcome
Losses
> 20%
Limited
intervention
Quality of
evidence1
Evidence
of effect

Trent 2013------------Highno

Jay 1984-------1---Moderateno

Gilliam 2004-------1---Moderateno

Hou 2010----------1Moderateno

Berenson 2012-------1---Moderateyes

Canto De Cetina 2001-1-1------Lowyes

Keder 1998-------1-1Lowno

Kirby 2010----1-1---Lowno

Castaño 2012----1-1---Lowyes

 1RCTs were considered high quality then downgraded a level for each of the following: a) randomization sequence generation and allocation concealment: no information on either, or one was inadequate; b) outcomes all self-reported or data unavailable for objective outcomes; c) losses > 20%; d) intervention focused on reminders without additional health education.